[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Hansoh Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":586},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,44,70,93,110,133,159,179,202,223,251,274,294,317,337,361,384,407,433,456,482,506,526,549,570],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100652757","phase-1-a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-hs-10582-in-healthy-subjects-and-subjects-with-mildly-elevated-ldl-c-levels-100652757",false,"NCT07777003","A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 Tablets After Single and Multiple Oral Doses in Healthy Subjects and Subjects With Mildly Elevated LDL-C","Inclusion Criteria:\n\n* For all participants\n* Participants have a full understanding of the study content, process, and possible adverse reactions, are willing to complete the study in strict accordance with the study protocol, and voluntarily sign the ICF;\n* Participants must be 18 to 55 years of age (inclusive) at the time of signing the ICF;\n* Body mass index (BMI) between 19.0 and 32.0 kg\u002Fm2 (inclusive), with body weight not less than 50.0 kg for males and not less than 45.0 kg for females;\n\nExclusion Criteria:\n\n* Participants with clinically significant abnormal vital signs, physical examination, or laboratory results as judged by the investigator during the screening period;\n* Pregnant or lactating women;\n* Any medication taken within 2 weeks or 5 half-lives (whichever is longer) before screening and any medication expected to be taken throughout the study, including prescription drugs, over-the-counter drugs, Chinese herbal medicine, and health products (except for medications used to treat AEs);\n* Participants with concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) and symptoms of gastrointestinal disorders; or any condition that may affect the absorption of drugs, such as partial or total gastrectomy, gastric bypass, and resection of any intestinal area;\n* Those who should not be enrolled per the investigator's opinion.\n* History of severe allergic\u002Fhypersensitivity reactions or persistent clinically significant allergic\u002Fhypersensitivity reactions, or history of hypersensitivity reactions to drugs with a chemical structure similar to HS-10582 as judged by the investigator;\n* Have participated in clinical studies of any drug or medical device and received at least one treatment (including placebo) within 12 weeks before screening, or are still within 5 half-lives of the investigational drug (whichever is longer, except for those who have not received the investigational drug or device);",true,"ALL","18 Years","55 Years",{"count":22,"type":23},76,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C.\n\nThis study will consist of two parts: single ascending dose (SAD) and multiple ascending dose (MAD).",[29],"Dyslipidemia",[31],"Elevated LDL-C；Hypercholesterolemia","NOT_YET_RECRUITING","2026-08-17",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":23},"2026-09-30",{"date":40,"type":23},"2027-12-31",{"name":42,"class":43},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100652207","phase-1-a-phase-i-clinical-trial-to-evaluate-pharmacokinetics-of-hs-10504-100652207","NCT07770217","A Phase I Clinical Trial to Evaluate Pharmacokinetics of HS-10504","A Phase I Clinical Trial to Evaluate the Effect of Rifampin on the Pharmacokinetics of HS-10504 in Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form prior to the study, fully understand the study content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the protocol;\n2. Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);\n3. Agree to pratice highly effective contraception from the signing of the informed consent form until 6 months after the last dose of HS-10504 and have no plans for reproduction or sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, chest X-ray (posteroanterior and lateral views), clinical laboratory tests, etc., during the screening period, which are deemed unsuitable for enrollment by the investigator.\n2. Subjects with a history of severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems, or currently having such diseases, or newly diagnosed diseases before administration of the investigational product, which are assessed by the investigator as unsuitable for participation in this trial.\n3. Subjects who have had surgery within 3 months prior to screening, or have planned surgery during the trial, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator.\n4. Subjects who have participated in any other clinical trial and received any investigational drug\u002Fdevice within 3 months prior to screening.\n5. Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of hypersensitivity to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.\n6. Subjects with a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or those with a positive result in drug abuse screening.\n7. Subjects who are habitual drinkers within 3 months prior to screening, or those who cannot abstain from alcohol during the trial, or those with a positive breath alcohol test during screening.\n8. Subjects who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or those who cannot refrain from using any tobacco products during the trial.\n9. Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening.\n10. Subjects who have had significant blood loss (≥400 mL) or donated blood within 3 months prior to screening, or donated blood or lost blood ≥200 mL within 1 month, or those who plan to donate blood during the trial.\n11. Subjects who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical agents with local effects) within 30 days prior to the first dose of the investigational product, or who have used any drug within a period less than 7 half-lives (whichever is longer) before dosing.\n12. Subjects who are lactating within 1 month prior to screening or during the trial, or female participants with a positive pregnancy test, or those who have had unprotected sexual intercourse within 14 days prior to screening.\n13. Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia.\n14. Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia.\n15. Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.",{"count":52,"type":23},18,[26],"This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.",[56],"Healthy Participants",[58,59,60,61],"Phase I","Drug interaction","HS-10504","Healthy participants","2026-08-13",{"date":64,"type":36},"2026-08-18",{"date":66,"type":23},"2026-08-02",{"date":68,"type":23},"2026-11-29",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":17,"sex":77,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100651905","phase-1-a-mass-balance-study-of-14chs-10504-100651905","NCT07764705","A Mass Balance Study of [14C]HS-10504","A Mass Balance Study of [14C]HS-10504 in Healthy Adult Male Chinese Participants","Inclusion Criteria:\n\n1. Subjects must be healthy adult males.\n2. Aged 18 years or older.\n3. BMI between 19.0 and 26.0 kg\u002Fm² (inclusive) and weight no less than 50 kg (inclusive).\n4. Able and willing to provide written informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, thyroid function, coagulation function, urinalysis, stool routine and occult blood), 12-lead electrocardiogram, ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), chest X-ray (posteroanterior view), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, and spleen), urinary system ultrasound (kidney, ureter, bladder, and prostate), echocardiography, etc.;\n2. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (except topical agents with local effects) within 30 days prior to screening, or use of any drug with a washout period of less than 7 half-lives (whichever is longer) before screening;\n3. Participation in other clinical trials and use of other investigational drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study;\n4. History of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to cardiovascular, respiratory, endocrine, neurological, digestive, urinary, or hematological, immune, psychiatric, or metabolic diseases; or onset of a new illness before study drug administration that is considered by the investigator to make the subject unsuitable for participation;\n5. Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed;\n6. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant;\n7. Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs\u002Ffoods), or history of severe allergy;\n8. Lactose intolerance;\n9. Habitual constipation or diarrhea;\n10. Frequent alcohol consumption within 3 months prior to screening, or inability to abstain from alcohol products during hospitalization; or a positive alcohol breath test at screening;\n11. Average daily cigarette consumption \\>5 cigarettes or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain from any tobacco products during hospitalization;\n12. Drug abuse, or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine, etc.) within 1 year prior to screening; or a positive urine drug abuse (illicit drug) test at screening;\n13. Employment in occupations requiring long-term exposure to radioactive conditions; or significant radiation exposure within 1 year prior to the study, or participation in radiopharmaceutical labeling studies within 1 year prior to the study;\n14. Vaccination within 1 month prior to screening, or planned vaccination during the study;\n15. History of syncope due to needle or blood, difficulty in blood sampling, or intolerance to venipuncture;\n16. Plans to father a child or donate sperm (for male participants) from signing of informed consent to 1 year after study completion, or unwillingness to adopt strict contraceptive measures with their spouse\u002Fpartner during this period;\n17. Blood loss ≥400 mL or blood donation within 3 months prior to screening; or blood loss ≥200 mL within 1 month; or blood transfusion within 1 month; or planned blood donation within 3 months after study completion;\n18. Special dietary requirements that cannot be complied with the standardized diet;\n19. Other reasons judged by the investigator as unsuitable for participation, or withdrawal of the participant's own accord.","MALE",{"count":79,"type":23},6,[26],"This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \\[14C\\] HS-10504 in healthy adult male subjects.",[83],"Healthy Subjects",[58,85,60,61],"Mass balance",{"date":87,"type":36},"2026-08-14",{"date":89,"type":23},"2026-07-30",{"date":91,"type":23},"2027-12-30",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":24,"phases":102,"briefSummary":54,"conditions":103,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100651869","phase-1-a-phase-i-clinical-trial-to-evaluate-the-effect-of-itraconazole-on-the-pharmacokinetics-of-hs-10504-100651869","NCT07764692","A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504","A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 in Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form prior to the study, fully understand the study content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the protocol;\n2. Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);\n3. Agree to practice highly effective contraception from the signing of the informed consent form until 6 months after the last dose of HS-10504 and have no plans for reproduction or sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, chest X-ray (posteroanterior and lateral views), clinical laboratory tests, abdominal and renal ultrasound, etc., during the screening period, which are deemed unsuitable for enrollment by the investigator.\n2. Subjects with a history of severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems, or currently having such diseases, or newly diagnosed diseases before administration of the investigational product, which are assessed by the investigator as unsuitable for participation in this trial.\n3. Subjects who have had surgery within 3 months prior to screening, or have planned surgery during the trial, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator.\n4. Subjects who have participated in any other clinical trial and received any investigational drug\u002Fdevice within 3 months prior to screening.\n5. Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of hypersensitivity to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.\n6. Subjects with a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or those with a positive result in drug abuse screening.\n7. Subjects who are habitual drinkers within 3 months prior to screening, or those who cannot abstain from alcohol during the trial, or those with a positive breath alcohol test during screening.\n8. Subjects who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or those who cannot refrain from using any tobacco products during the trial.\n9. Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening.\n10. Subjects who have had significant blood loss (≥400 mL) or donated blood within 3 months prior to screening, or donated blood or lost blood ≥200 mL within 1 month, or those who plan to donate blood during the trial.\n11. Subjects who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical agents with local effects) within 30 days prior to the first dose of the investigational product, or who have used any drug within a period less than 7 half-lives (whichever is longer) before dosing.\n12. Subjects who are lactating within 1 month prior to screening or during the trial, or female participants with a positive pregnancy test, or those who have had unprotected sexual intercourse within 14 days prior to screening.\n13. Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia.\n14. Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia.\n15. Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.",{"count":101,"type":23},8,[26],[56],{"date":87,"type":36},{"date":106,"type":23},"2026-08-01",{"date":108,"type":23},"2027-03-31",{"name":42,"class":43},{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100651770","phase-2-a-phase-2-study-of-hs-20118-to-evaluate-the-efficacy-and-safety-in-participant-with-moderate-to-severe-plaque-psoriasis-100651770","NCT07765628","A Phase 2 Study of HS-20118 to Evaluate the Efficacy and Safety in Participant With Moderate-to-Severe Plaque Psoriasis","A Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HS-20118 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Participants voluntarily agree to comply with all study procedures and scheduled follow-up assessments, and to cooperate with the collection of lesion photographs and other protocol-specified requirements;\n2. Diagnosis of plaque psoriasis, with or without PsA, established for at least 26 weeks prior to the first administration of study intervention. If previously diagnosed with psoriasis, participants must have a documented history of psoriasis for at least 26 weeks and must be confirmed by the investigator during screening to have plaque psoriasis;\n3. At screening and baseline, participants must be confirmed by the investigator to have stable moderate-to-severe plaque psoriasis, as defined by meeting all of the following four criteria:\n\n1\\) No morphological changes or significant disease flares during the 4 weeks preceding screening, as assessed by the investigator; 2) BSA≥10%； 3) PASI≥12； 4) IGA≥3； 4. Be a candidate for phototherapy or systemic treatment for plaque psoriasis; 5. Participants must have no plans for pregnancy or sperm\u002Fegg donation during the study period. If of childbearing age, women must not be pregnant or breastfeeding, and must have a negative blood pregnancy test within 7 days before randomization. Participants and their partners must voluntarily use highly effective contraception during the study period and for at least 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Known allergy, hypersensitivity, or intolerance to biologics, study drugs, or their excipients.\n2. Non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) at screening or randomization.\n3. Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.\n4. Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.\n5. Severe, progressive, or poorly controlled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematologic, rheumatologic, psychiatric, or metabolic disorders; or current signs or symptoms related to these conditions.\n6. History of malignancy within 5 years before screening (except for adequately treated skin basal cell carcinoma, in situ skin cancer, or in situ cervical cancer with no recurrence for at least 12 weeks before the first dose).\n7. History of lymphoproliferative disorders (e.g., lymphoma), unexplained monoclonal gammopathy, or signs and symptoms suggestive of lymphoproliferative disorders (e.g., splenomegaly or severe lymphadenopathy).\n8. Any other condition deemed by the investigator as unsuitable for participation in the clinical study.",{"count":118,"type":23},120,[120],"PHASE2","The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.",[123],"Moderate to Severe Plaque Psoriasis",[125],"Plaque psoriasis","2026-08-11",{"date":87,"type":36},{"date":129,"type":23},"2026-08-06",{"date":131,"type":23},"2027-07-10",{"name":42,"class":43},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100651321","phase-3-a-study-to-evaluate-the-long-term-safety-of-hs-10380-in-patients-with-schizophrenia-100651321","NCT07759869","A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia","Inclusion Criteria:\n\n* Participant is aged 18-65 years, inclusive, at screening.\n* Body mass index must be ≥18.0 and ≤40.0 kg\u002Fm² at screening.\n* Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria.\n* Willing and able to give informed consent\u002Fassent as per local requirements.\n* Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator.\n\nExclusion Criteria:\n\n* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.\n* Judged by the investigator as having treatment-resistant schizophrenia.\n* Patients with risk of violent or destructive behavior, or suicidal risk.\n* History or presence of clinically significant disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.\n* Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria.\n* History of severe allergic reactions.\n* Female patients who are pregnant, in puerperium, or lactating at screening or baseline.\n* History of drug abuse within 1 year prior to screening.\n* History of alcohol abuse within 6 months prior to screening.\n* Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .","65 Years",{"count":142,"type":23},500,[144],"PHASE3","The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.",[147],"SCHIZOPHRENIA 1 (Disorder)",[149],"Schizophrenia, Long-term, open-label, HS-10380","2026-08-07",{"date":152,"type":36},"2026-08-12",{"date":154,"type":23},"2026-09-09",{"date":156,"type":23},"2028-08-31",{"name":42,"class":43},1,{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":24,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100651015","phase-iii-study-of-hs-10504-versus-platinum-based-doublet-chemotherapy-in-patients-with-c797s-nsclc-100651015","NCT07754123","Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC","A Randomized, Controlled, Open-Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR C797S Mutation After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV).\n3. Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation.\n4. At least one measurable target lesion per RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Presence of other well-documented driver gene mutations (e.g., ALK fusion, ROS1 fusion, KRAS activating mutations, MET exon 14 skipping, HER2 mutations, RET fusion).\n2. Histological or phenotypic transformation (e.g., NSCLC to SCLC transformation, epithelial-to-mesenchymal transition) confirmed by tumor tissue obtained within 6 months prior to first dose.\n3. ≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity).\n4. History of other primary malignancies.\n5. Inadequate bone marrow reserve or hepatic\u002Frenal organ function.\n6. Clinically significant cardiac abnormalities or severe\u002Funcontrolled\u002Factive cardiovascular disease.\n7. Poorly controlled diabetes mellitus or hypertension.\n8. Significant clinical bleeding tendency or history of severe arterial\u002Fvenous thromboembolic events.\n9. Severe or uncontrolled active infection.\n10. Continuous systemic corticosteroid therapy (\\>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use.\n11. Active infectious diseases (e.g., active hepatitis B virus \\[HBV\\] infection).\n12. Clinically significant gastrointestinal disorders.\n13. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.\n14. Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity.\n15. History of severe neurological or psychiatric disorders.",{"count":167,"type":23},206,[144],"This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.",[171],"Advanced or Metastatic NSCLC",{"date":173,"type":36},"2026-08-10",{"date":175,"type":23},"2026-09-17",{"date":177,"type":23},"2031-07-31",{"name":42,"class":43},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":158},"100648153","phase-1-a-phase-i-study-of-single-and-multiple-doses-of-hs-20136-2-injection-in-healthy-or-obese-participants-100648153","NCT07716241","A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants","A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administration of HS-20136-2 Injection in Healthy\u002FObese Participants","Inclusion Criteria:\n\n1. Aged between 18 and 55 years (inclusive) at screening, male or female.\n2. Participants must fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the informed consent form (ICF) prior to any study-related procedures.\n3. Agree to use effective contraceptive measures and refrain from sperm or egg donation from the time of signing the ICF until 4 months after the last dose.\n4. Agree to abstain from alcohol, smoking, and food or beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.), and refrain from strenuous exercise from 48 hours prior to dosing until discharge from the study site.\n5. Self-reported body weight fluctuation of ≤ 5.0% within 12 weeks prior to screening through diet and exercise control alone.\n6. Willing and able to maintain a stable diet and exercise lifestyle throughout the study period.\n7. SAD cohort: body weight ≥ 50 kg, BMI 19.0-28.0 kg\u002Fm² (inclusive). MAD cohort: BMI 28.0-40.0 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurological, hematological, immunological, or metabolic disorders (e.g., recurrent hypoglycemia of unknown cause) that, in the investigator's opinion, would make the participant unsuitable for participation in this study.\n2. Clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.\n3. Presence of diseases that, in the investigator's judgment, may significantly affect drug or nutrient absorption, including clinically significant gastrointestinal disorders (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disturbance; or any condition that may affect drug absorption, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, or resection of any intestinal segment.\n4. Diagnosis of chronic pancreatitis or history of idiopathic acute pancreatitis, or serum amylase or lipase above the upper limit of normal (ULN) at screening. Participants with a history of acute pancreatitis due to cholelithiasis may be enrolled if they have undergone cholecystectomy.\n5. History of acute cholecystitis, or presence of symptomatic\u002Fstone-related cholelithiasis requiring treatment on prior or screening ultrasound (except for participants who have undergone cholecystectomy and are deemed eligible by the investigator).\n6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2), or screening calcitonin level ≥ 50 ng\u002FL.\n7. Participation in any other clinical trial of a drug or medical device within 3 months prior to screening (excluding those who did not receive the investigational product or device).\n8. History of diabetes mellitus (type 1, type 2, or rare forms of diabetes).\n9. Presence of endocrine disorders or history thereof that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism; except for hypothyroidism managed with a stable thyroid hormone replacement regimen for at least 6 months), or obesity due to single-gene mutations or hereditary obesity syndromes.\n10. Use of any medication or treatment known to cause significant weight gain or weight loss within 3 months prior to screening.\n11. Any other condition that, in the investigator's opinion, would make the participant unsuitable for enrollment in this study.",{"count":187,"type":23},92,[26],"The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy\u002Fobese participants.",[191],"Obesity",[193],"obesity","2026-07-16",{"date":196,"type":36},"2026-07-21",{"date":198,"type":23},"2026-09-22",{"date":200,"type":23},"2027-05-14",{"name":42,"class":43},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":4},"100646897","phase-1-an-open-label-fixed-sequence-phase-i-clinical-trial-to-evaluate-the-effect-of-hs-10504-on-the-pharmacokinetics-of-midazolam-in-patients-with-non-small-cell-lung-cancer-100646897","NCT07685041","An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n2. Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC\n3. Confirmed EGFR mutation positivity in participants before enrollment.\n4. At least one target lesion according to RECIST 1.1\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with no deterioration in the 2 weeks prior to the first dose\n6. Minimum life expectancy greater than 12 weeks\n7. Female participants of childbearing potential must agree to use appropriate contraception (refer to section 12.5) from the time of signing informed consent until 6 months after the last dose, and should not breastfeed; male participants must agree to use barrier contraception (i.e., condoms) from the time of signing informed consent until 6 months after the last dose\n8. Willing to participate in this clinical trial, understand the study procedures, and be able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Has received or is currently receiving the following treatments:\n\n   1. Prior or current treatment with a fourth-generation EGFR tyrosine kinase inhibitor.\n   2. Use of strong\u002Fmoderate inhibitors or strong\u002Fmoderate inducers of CYP3A4, CYP3A5, CYP2C8, and\u002For CYP2D6, or narrow therapeutic index drugs that are sensitive substrates of CYP3A4, CYP3A5, P-gp, and BCRP within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product; or need to continue these medications during the study period.\n   3. Use of drugs that affect gastric acid secretion or intragastric pH within 7 days prior to the first dose of investigational product.\n   4. Currently receiving treatment with drugs known to prolong the QT interval or that may cause torsade de pointes; or need to continue these medications during the study period\n2. Presence of toxicities from prior anti-tumor therapy that have not resolved to \\\u003C Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\n3. History of other primary malignancies.\n4. Inadequate bone marrow reserve or hepatic\u002Frenal organ function.\n5. Meets any of the following cardiac criteria:\n\n   1. Mean Fridericia-corrected QT interval (QTcF) \\> 470 msec on resting electrocardiogram (ECG);\n   2. Resting ECG shows any clinically significant rhythm, conduction, or ECG morphological abnormality deemed important by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval \\> 250 msec, etc.);\n   3. Presence of any factors that increase the risk of QT prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication that prolongs the QT interval;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n6. Severe, uncontrolled, or active cardiovascular disease.\n7. Severe or poorly controlled diabetes mellitus.\n8. Severe or poorly controlled hypertension.\n9. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n10. Severe arterial thrombotic event within 3 months prior to the first dose.\n11. Severe infection within 4 weeks prior to the first dose.\n12. Continuous corticosteroid therapy for more than 30 days within 30 days prior to the first dose, or need for long-term corticosteroid therapy, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation\n13. Known active infectious disease.\n14. Clinically severe gastrointestinal abnormalities that may affect drug intake, transport, or absorption.\n15. Hepatic encephalopathy, hepatorenal syndrome, or ≥C (incomplete in original).\n16. Other moderate to severe pulmonary diseases that seriously impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.\n17. Previous history of severe neurological or psychiatric disorders.\n18. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n19. History of severe allergies, or hypersensitivity to any component of HS-10504 tablets or midazolam oral solution, or history of hypersensitivity to drugs with a similar chemical structure or of the same class as HS-10504.\n20. History of ventilation difficulty or severe airway obstruction.\n21. Any severe or uncontrolled ocular condition that, in the physician's judgment, may increase the patient's risk; or ocular abnormalities requiring surgery or expected to require surgical treatment during the study period.\n22. Participants who, in the investigator's judgment, may have poor compliance with study procedures and requirements.\n23. In the investigator's judgment, presence of any life-threatening complication.",{"count":209,"type":23},24,[26],"This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.",[213],"NSCLC",[58,59,60,213],"2026-06-29",{"date":217,"type":36},"2026-07-06",{"date":219,"type":23},"2026-06-27",{"date":221,"type":23},"2027-07-20",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":24,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100645001","phase-3-a-study-to-evaluate-the-safety-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100645001","NCT07677384","A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder","A Multicenter, Open-label, Phase 3 Study to Evaluate the Short-term and Long-term Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. Participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;\n5. For new Participants: Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n6. For new Participants: Participants must have Insomnia Severity Index (ISI) scores≥15 at screening;\n7. For new Participants: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least three nights every week within one month prior to screening; and sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before the first dose in the open-label treatment period;\n\nExclusion Criteria:\n\n1. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n2. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n3. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n4. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n5. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n6. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n7. Has a history of smoking≥10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n8. Has a history of caffeine consumption≥600 mg per day or can't obey the rules of caffeine restriction;\n9. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n10. Has taken more than 3 naps per week for\\>1 hour each time within the past 2 weeks prior to screening;\n11. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.\n12. For Participants completed Study 301: Has been diagnosed with a sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder during Study 301, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n13. For Participants completed Study 301: Has been diagnosed with neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases during Study 301; or other systemic diseases that are inappropriate for the study;\n14. For Participants completed Study 301: Previously participated in any clinical trial other than HS-10506-301 within 3 months prior to screening;\n15. For new Participants: Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n16. For new Participants: Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n17. For new Participants: Previously use of HS-10506;\n18. For new Participants: Previously participated in any clinical trial within 3 months prior to screening.","64 Years",{"count":232,"type":23},600,[144],"The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.",[236],"Insomnia Disorder",[238,239,240,241,242],"Clinical trial","insomnia disorder","open-label","long-term","phase 3","2026-06-24",{"date":245,"type":36},"2026-06-30",{"date":247,"type":23},"2026-06-12",{"date":249,"type":23},"2029-06-30",{"name":42,"class":43},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":258,"targetDuration":4,"studyType":24,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":158},"100630112","phase-1-a-study-of-hs-20136-2-in-healthy-participants-100630112","NCT07483437","A Study of HS-20136-2 in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Administration of HS-20136-2 Injection in Healthy Participants","Inclusion Criteria:\n\n1. Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form;\n2. Healthy men and women aged 18-65 years (inclusive);\n3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) \\[BMI = body weight\u002Fbody height2 (kg\u002Fm2)\\];\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Participants with a history of cardiovascular, respiratory, hepatic, renal, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities (such as unexplained recurrent hypoglycemia) and other diseases, and not suitable for the study as assessed by the investigator, such as: Childhood asthma (resolved),Depression (non-hospitalised, but potentially medicated in the past), Migraine, etc.\n3. Glycosylated hemoglobin A1c (HbA1c) \\> 6.5% or fasting blood glucose ≤ 3.9 mmol\u002FL (70 mg\u002FdL) or ≥ 6.1 mmol\u002FL (110 mg\u002FdL) during the screening period;\n4. The alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin (TBIL) \\> 1.5 × ULN during the screening period (except for cases of known Gilbert's Syndrome);\n5. Participating in any clinical study involving drugs or medical devices (except for those not receiving an investigational drug or investigational device) within 3 months before screening or 5 half-lives (whichever is longer) before screening, or currently participating in a clinical trial;\n6. Treatment with systemic steroids, immunomodulators, or chemotherapy within 3 months before screening or likely to receive them during the study;\n7. Known severe allergic disease, or known allergies to GLP-1R agonists or Retatrutide, or allergic constitution (allergies to various drugs and foods);\n8. With concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) and symptoms of gastrointestinal disorders; or any condition that might affect the absorption of drugs, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, and resection of any intestinal area;\n9. History of confirmed chronic pancreatitis or idiopathic acute pancreatitis, or serum amylase or lipase greater than the upper limit of normal at screening. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem;\n10. Have a history of symptomatic gallbladder disease within the past 2 years, defined by the presence of gallstones on an imaging study and abdominal pain attributed to the gallstones by the participant's physician; subjects who had a procedure to remove the gallstones and\u002For the gallbladder (cholecystectomy), with no long-term complications, are eligible for participation as long as the procedure was completed at least 3 months prior to screening;\n11. Diet or weight loss treatment within 3 months prior to administration (regardless of the reason) or having body weight change of more than 5% or a significant change in living habits within 3 months prior to administration;\n12. Other reasons for exclusion, as determined by the investigator.",{"count":259,"type":23},38,[26],"This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.",[263],"Healthy",[265],"HS-20136-2，single ascending dose，safety，tolerability","2026-05-28",{"date":268,"type":36},"2026-06-01",{"date":270,"type":23},"2026-05-15",{"date":272,"type":23},"2026-12-31",{"name":42,"class":43},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100637573","phase-1-phase-1-study-of-hs-10541-as-monotherapy-or-in-combination-with-other-anti-cancer-therapies-in-patients-with-kras-g12c-mutation-advanced-solid-tumors-100637573","NCT07615413","Phase 1 Study of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Patients With KRAS G12C Mutation Advanced Solid Tumors.","A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Participants With KRAS G12C Mutation Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntary participation and written informed consent..\n2. Aged 18 years or older (≥18 years), of any gender.\n3. Histologically or cytologically confirmed advanced solid tumor.\n4. At least one measurable lesion according to RECIST v1.1.\n5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.\n6. With a life expectancy \\> 12 weeks.\n7. Adequate bone marrow reserve and organ function.\n8. Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose.\n9. Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose.\n\nExclusion Criteria:\n\n1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.\n2. Presence of symptomatic brain metastases, leptomeningeal\u002Fbrainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.\n3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.\n4. History of a second primary malignancy\n5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.\n6. Severe or poorly controlled diabetes mellitus or hypertension.\n7. Known active infectious diseases.\n8. Clinically significant gastrointestinal dysfunction.\n9. Gastrointestinal obstruction or perforation occured.\n10. Interstitial lung disease (ILD).\n11. Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class.\n12. Other inappropriate situation considered by the investigator.",{"count":282,"type":23},636,[26],"This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.",[286],"KRAS G12C Mutation Advanced Solid Tumor","2026-05-22",{"date":289,"type":36},"2026-05-29",{"date":245,"type":23},{"date":292,"type":23},"2029-12-30",{"name":42,"class":43},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":301,"targetDuration":4,"studyType":24,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100640012","phase-1-a-phase-i-single-and-multiple-dose-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-hs-10522-in-healthy-chinese-participants-and-chinese-participants-with-mild-hypertension-100640012","NCT07609875","A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension","Inclusion Criteria:\n\n\\-\n\nFor all participants:\n\n1. Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).\n2. Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.\n3. At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.\n2. Presence of orthostatic hypotension or orthostatic tachycardia at screening.\n3. Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.\n4. Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.\n5. Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).\n6. Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).\n7. Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.",{"count":302,"type":23},88,[26],"The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.",[306,307],"Healthy Adult","Hypertension",[309],"hypertension","2026-05-19",{"date":312,"type":36},"2026-05-27",{"date":268,"type":23},{"date":315,"type":23},"2027-02-03",{"name":42,"class":43},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":324,"targetDuration":4,"studyType":24,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100640374","phase-3-a-study-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100640374","NCT07587385","A Study of HS-10506 in Chinese Patients With Insomnia Disorder","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n5. Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;\n6. Subjective sleep assessment: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least three nights every week within one month prior to screening; and sSOL ≥ 30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before V2 visit and V3 visit respectively;\n7. PSG: Participants must demonstrate a 2-night mean LPS ≥ 30 minutes with neither night \\\u003C 20 minutes, a 2-night mean WASO ≥ 30 minutes with neither nigh \\\u003C 20 minutes, and a 2-night mean TST \\\u003C 7 hours.\n\nExclusion Criteria:\n\n1. Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n2. Has a Apnea-Hypopnea Index (AHI) ≥ 10 times\u002Fhour or periodic leg movement with arousal index (PLMAI) ≥ 10 times\u002Fhour monitored by PSG at V2 visit;\n3. Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n4. Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;\n5. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n6. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n7. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n8. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n9. Has taken more than 3 naps per week for \\> 1 hour each time within the past 2 weeks prior to screening;\n10. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n11. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n12. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n13. Has a history of smoking ≥ 10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n14. Has a history of caffeine consumption ≥ 600 mg per day or can't obey the rules of caffeine restriction;\n15. Previously participated in any clinical trial of HS-10506;\n16. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the participant's full participation in the study or compliance with the protocol.",{"count":325,"type":23},732,[144],"The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.",[236],[238,239,242],"2026-05-08",{"date":332,"type":36},"2026-05-14",{"date":289,"type":23},{"date":335,"type":23},"2028-08-12",{"name":42,"class":43},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":4},"100636605","phase-1-a-study-of-hs-10587-in-patients-with-advanced-solid-tumors-100636605","NCT07567859","A Study of HS-10587 in Patients With Advanced Solid Tumors","An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.\n2. Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.\n3. Evidence of MTAP deletion in the tumor tissue.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥12 weeks.\n6. At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n7. Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.\n\nExclusion Criteria:\n\n1. History of other primary malignancies.\n2. Presence of pleural\u002Fabdominal effusion or pericardial effusion requiring clinical intervention.\n3. Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic\u002Funstable brain metastases.\n4. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).\n5. Inadequate bone marrow reserve or hepatic and renal functions.\n6. Severe, uncontrolled, or active cardiovascular diseases.\n7. Severe or poorly controlled diabetes.\n8. Severe or poorly controlled hypertension.\n9. Severe infection within 4 weeks prior to the first dose.\n10. Long-term corticosteroid therapy, history of other acquired\u002Fcongenital immunodeficiency disorders, or organ transplantation.\n11. Known active infectious diseases.\n12. Clinically significant gastrointestinal dysfunction.\n13. Moderate to severe pulmonary diseases that seriously affect respiratory function.\n14. Prior history of severe neurological or mental disorders.\n15. Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.\n16. History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.\n17. Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.","75 Years",{"count":346,"type":23},362,[26],"This is a Phase I, multicenter, open-label clinical trial with dose escalation\u002Fdose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.",[350],"MTAP Deletion",[352],"Advanced Solid Tumors","2026-04-28",{"date":355,"type":36},"2026-05-05",{"date":357,"type":23},"2026-06-04",{"date":359,"type":23},"2028-06-30",{"name":42,"class":43},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":24,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":158},"100635620","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-participants-with-chronic-kidney-disease-100635620","NCT07555054","A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease","A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Men and women aged 18-70 years old;\n2. Body mass index (BMI) ≥18.0 and \\\u003C50.0 kg\u002Fm\\^2 at screening;\n3. Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and\u002For ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;\n4. Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2 calculated using the 2021 CKD-EPI creatine formula at screening;\n5. Urinary albumin\u002Fcreatinine ratio (UACR) was ≥300 and \\\u003C3000 mg\u002Fg for at least 2 times on different days detected by the local laboratory at screening;\n6. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;\n7. Agree to contraception.\n\nExclusion Criteria:\n\n1. A known or suspected allergy to the investigational medical drug or its components or excipients;\n2. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;\n3. If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;\n4. Participants with uncontrolled diabetes mellitus (HbA1c \\> 8%);\n5. Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;\n6. Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;\n7. Acute kidney injury or dialysis treatment within 6 months before screening;\n8. Received kidney transplant, or plan to receive kidney transplant during the trial;\n9. Platelet\\\u003C 100×10\\^9\u002FL or hemoglobin value \\\u003C 90 g\u002FL or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at screening;\n10. Elevations of transaminases (ALT and\u002For AST) \\>3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;\n11. Serum potassium \\>5.5 mmol\u002FL at screening.","70 Years",{"count":370,"type":23},182,[120],"The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg\u002Fg and \\\u003C 3000 mg\u002Fg",[374],"Chronic Kidney Disease",[376],"chronic kidney disease","2026-04-21",{"date":353,"type":36},{"date":380,"type":23},"2026-05-21",{"date":382,"type":23},"2028-12-31",{"name":42,"class":43},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":158},"100634152","phase-1-a-phase-i-study-to-evaluate-the-effect-of-itraconazole-on-the-pharmacokinetics-of-hs-10506-in-healthy-chinese-adult-participants-100634152","NCT07535970","A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants","Inclusion Criteria:\n\n1. Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;\n2. Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);\n3. Participant's Body Mass Index (BMI) = weight (kg) \u002F height² (m²) within the range of 19.0-26.0 kg\u002Fm² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;\n4. Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm\u002Fegg donation during this period (only non-drug contraceptive measures are permitted during the trial).\n\nExclusion Criteria:\n\n1. Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;\n2. Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;\n3. 12-lead electrocardiogram results during the screening period showing QTcF\\>450.00 ms for males or QTcF\\>470.00 ms for females;\n4. Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;\n5. Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;\n6. Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.);\n7. Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF;\n8. History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment;\n9. Participation in any other clinical trial involving any investigational drug or device within 3 months before screening, or within 7 half-lives of another investigational drug before screening, whichever is longer;\n10. Prone to allergic reactions, or allergic constitution(e.g., allergies to pollen, two or more drugs\u002Ffoods), or known allergy to components of HS-10506 tablets or itraconazole capsules;\n11. History of drug abuse, drug dependence, or use of illicit drugs within 5 years before screening, or positive drug abuse screening results;\n12. Frequent alcohol consumption within 3 months before screening (i.e., consuming more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, equivalent to 10 bottles of beer, 500 mL spirits, or 3 bottles of wine per week), or inability to stop consuming alcoholic products during the trial, or positive alcohol breath test;\n13. Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to stop using any tobacco products during the trial;\n14. Excessive consumption of tea, coffee, and\u002For caffeinated beverages within 3 months before screening (average of more than 8 cups per day; 1 cup = 200 mL);\n15. Significant blood loss(≥200 mL)or blood donation within 3 months before screening, or plans for blood donation during the study or within 3 months after the study;\n16. Use of any drugs affecting CYP3A, CYP2C19 enzymes, or drugs altering gastric acid \\[proton pump inhibitors (PPIs), H2 receptor antagonists, topical antacids, oral alkaline drugs, etc.\\] within 30 days before the first dose of investigational product(or within 7 times the corresponding elimination half-life, whichever is longer);\n17. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements(excluding topical preparations with local effects) within 14 days before the first dose of investigational product, or use of any drug within 7 half-lives (whichever is longer);\n18. Consumption of grapefruit or grapefruit products within 48 hours before the first dose of investigational product;\n19. Vaccination within 30 days before the first dose of investigational product, or planned use of vaccines during the study or within two weeks after the study;\n20. Significant changes in diet or sleep habits within 4 weeks before screening, assessed by the investigator as unsuitable for participation in this study;\n21. Female participants who are pregnant, breastfeeding, or have a positive pregnancy test result within 1 month before screening or during the trial period;\n22. Unprotected sexual intercourse within 14 days before screening;\n23. Special dietary requirements, inability to comply with a unified diet, or difficulty swallowing;\n24. Intolerance to venipuncture\u002Findwelling needle blood collection or fear of needles\u002Fblood;\n25. Inability to complete the study for other reasons or deemed unsuitable for participation by the investigator.","45 Years",{"count":392,"type":23},20,[26],"A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.",[56],[397,59,398,399,56],"Phase 1","Itraconazole","HS-10506","2026-04-10",{"date":402,"type":36},"2026-04-17",{"date":404,"type":23},"2026-04-30",{"date":89,"type":23},{"name":42,"class":43},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":344,"enrollmentInfo":414,"targetDuration":4,"studyType":24,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":424,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":158},"100629139","phase-1-study-of-safety-and-efficacy-of-hs-10542-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-100629139","NCT07470762","Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria","A Phase IB\u002FII,Open Label Study to Assess Efficacy, and Safety, of HS-10542 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.\n2. It was confirmed to be PNH during screening, and the clone size of red blood cells or\u002Fand granulocytes or\u002Fand monocytes was detected by flow cytopy ≥10%\n3. Stable use of C5 complement inhibitor ikuzumab\u002Fcovalimab for the first 6 months of random treatment\n4. Have at least one blood transfusion record within the last 4 months, or sustain a hemoglobin level below 100g\u002FL the last 4 months prior to screening.\n5. The average hemoglobin level from two tests conducted by the laboratory at the time of screening is less than 100 g\u002FL, or hemoglobin level \\\u003C100g\u002FL before transfusion.\n6. LDH \\> 1.5 x Upper Limit of Normal (ULN) at the time of screening\n7. Inoccution of Neisseris meningitis and Streptococcus pneumoniae vaccine at least 2 weeks before the first administration of HS-10542;\n8. if HS-10542 treatment must begin less than 2 weeks after vaccination, preventive antibiotic treatment must begin at least 2 weeks after vaccination.\n9. Male and female subjects with fertility must agree to adopt efficient contraceptive measures with their partners within 60\u002F120 days from the signing of the informed consent form to the last administration,\n10. Male subjects who are infertile (such as those who have undergone effective sterilization surgery) must take additional efficient contraceptive measures when it is uncertain whether they have sperm，\n\nExclusion Criteria:\n\n1. Known or suspected hereditary or acquired complement deficiency\n2. Currently active primary or secondary immunodeficiency\n3. History of infection with pod bacteria (such as Neisseris meningitis, Streptococcus pneumoniae, etc.)\n4. Patients with laboratory evidence of bone marrow failure (reticulocytes \\\u003C100x109\u002FL; platelets \\\u003C30x109\u002FL; neutrophils \\\u003C0.5x109\u002FL);\n5. Presence of a bone marrow failure disorder (e.g., aplastic anemia, myelodysplastic syndrome, myelofibrosis)\n6. Presence of active anemia unrelated to PNH, such as renal anemia or anemia due to blood loss.\n7. There is or is suspected of systemic active bacteria, virus or fungal infection 2 weeks before the first administration of HS-10542 (according to the researcher's judgment)\n8. During screening, there are advanced heart disease (such as NYHA level IV),\n9. unstable thrombosis events that may exist for other causes,\n10. Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula \\> 450 msec for males and \\> 470 msec for females; or other clinically significant abnormalities as judged by the investigator.\n11. Major surgery within 3 months prior to the first dose. \\*Note: See Appendix for definitions of Grade 3\u002F4 surgeries.\n12. Known active infection requiring systemic therapy\n13. Diagnosed malignant tumors in the past 5 years\n14. Those who have a history of splenectomy or History of bone marrow\u002Fhematopoietic stem cells or solid organ transplantation\n15. Severe or poorly controlled hypertension\n16. poorly controlled diabetes\n17. Those who are suspected of being allergic to experimental drugs or any ingredient in experimental drugs\n18. Use any of the following drugs, unless there is a stable treatment plan before screening: a) erythropoietin (ESA), hypoxic-inducing factor proaminoyl hydroxylase inhibitor (HIF-PHI) or immunosuppressant for at least 8 weeks b) Systemic use of glucocorticoids (≤15 mg\u002Fday Prednisone or equivalent doses of glucocorticoids) at least 4 weeks c) Vitamin K antagonists (such as warfarin) have a stable international standardized ratio (INR) at least 4 weeks d) Low molecular weight heparin, oral anticoagulants such as aspirin, rvaroxaban, apifloxaban, etc. at least 4 weeks e) Iron supplements , vitamin B12, folic acid or androgen for at least 4 weeks\n19. Except for C5 complement inhibitors (including but not limited to ecucizumab and covalizumab), the situation of participating in other clinical trials or using other study drugs or approved therapies for experimental use before screening, and the trial drug is still within 5 half-lives or 2 weeks\n20. Participants who have previously received B-factor inhibitor treatment, with a treatment duration of no more than one week and having stopped taking the drug for more than five half-lives before screening, may not be excluded\n21. During screening, there are serious concurrent diseases, such as severe kidney disease (such as eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m2, dialysis),\n22. ALT\u002FALP\\>3×ULN,\n23. Screening positive blood pregnancy test and breastfeeding women at the time of the visit,",{"count":415,"type":23},50,[26,120],"This was a phase 1b\u002F2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.",[419],"Paroxysmal Nocturnal Hemoglobinuria",[421,422,423],"HS-10542","paroxysmal nocturnal hemoglobinuria（PNH）","CFB","RECRUITING","2026-04-09",{"date":427,"type":36},"2026-04-13",{"date":429,"type":36},"2026-02-14",{"date":431,"type":23},"2029-07-31",{"name":42,"class":43},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":440,"targetDuration":4,"studyType":24,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":158},"100631617","phase-1-phase-1-study-of-hs-20152-in-healthy-participants-100631617","NCT07503015","Phase 1 Study of HS-20152 in Healthy Participants","A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20152 in Healthy Participants","Inclusion Criteria:\n\n1. Males or females aged 18 to 64 years (inclusive) when signing the ICF.\n2. Body Mass Index (BMI = weight\u002Fheight²) ≥ 19 kg\u002Fm² and ≤ 28 kg\u002Fm² at screening, and males must weigh ≥50 kg, and females must weigh ≥ 45 kg.\n3. Female participants must agree to practice highly effective contraception from 2 weeks prior to screening until 6 months after dosing.\n4. Male participants with childbearing potential must agree to practice highly effective contraception from the date of signing the ICF until 6 months after dosing; male participants without childbearing potential (e.g, having undergone effective sterilization) must agree to use additional highly effective contraception if there is any uncertainty about the presence of sperm.\n5. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n6. The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this study, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the ICF voluntarily.\n\nExclusion Criteria:\n\n1. Consumption of any caffeine, tea, alcohol, xanthine-rich foods or beverages within 24 hours before dosing.\n2. Consumption of red wine, citrus fruits (such as grapefruit, oranges, tangerines, etc.), grapes, mangoes, or star fruits, or juices containing these fruits, within 72 hours prior to dosing.\n3. Abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, chest X-ray (anteroposterior and lateral)\u002FCT, or abdominal ultrasound at screening, which, in the investigator's judgement, may increase the participant's risk in the study or affect the interpretation of the study results.\n4. Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, or syphilis-specific antibodies at screening.\n5. Presence of non-active, active, or latent tuberculosis infection at screening (indicated by chest X-ray or CT showing tuberculosis lesions, or positive T-SPOT.TB results).\n6. Positive pregnancy test at screening, or pregnant or breastfeeding at screening, or planning to become pregnant during the study.\n7. Use of any medications, including prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or dietary supplements, within 2 weeks prior to screening, or within 5 half-lives after the last dose of such medications, whichever is longer.\n8. Receipt of any live attenuated vaccine within 30 days prior to dosing; receipt of any vaccine not specified in the protocol within 5 days prior to dosing; or planned receipt of any vaccine not specified in the protocol during the study.\n9. Participation in other drug or medical device intervention clinical trials within 1 month prior to screening, and receipt of investigational drugs or use of medical devices, or being within 5 half-lives of the last dose of other investigational drugs, whichever is longer; or adverse events (AEs) from other trials that have not resolved to CTCAE Grade 1 or normal at screening.\n10. Receipt of siRNA or antisense oligonucleotide therapy within 18 months prior to dosing.\n11. Blood donation or blood loss of ≥ 450 mL (excluding menstruation) within 3 months prior to screening, or planned blood donation during the study.\n12. Average smoking of \\> 5 cigarettes per day within 3 months prior to screening.\n13. Known history of drug abuse or drug use within 6 months prior to screening, or test positive for drug abuse at screening.\n14. Known history of alcohol dependence (average consumption of ≥14 units per week, with each unit equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of spirits) within 6 months prior to screening, or positive alcohol breath test at screening.\n15. Undergone ≥ Grade 2 surgery within 6 months prior to screening, or plan to have surgery or hospitalization during the study.\n16. History of severe allergies to medications, foods, or environmental factors, or known allergies to the active substances or excipients of the investigational product (including HS-20152 and placebo).\n17. History of infection with encapsulated organisms (such as Neisseria meningitidis or Streptococcus pneumoniae), or close contact with individuals infected with Neisseria meningitidis.\n18. Difficulty with blood draws, inability to tolerate multiple venous blood draws, or any contraindications to blood draws; or severe skin conditions that, in the investigator's judgement, make subcutaneous injection unsuitable.\n19. Special dietary requirements or inability to comply with the dietary requirements of the study site.\n20. As judged by the investigator, any prior or current disease or condition that may increase the risk to the participant from participating in the study, interfere with the participant's compliance with the protocol, or affect the participant's ability to complete the study.",{"count":441,"type":23},32,[26],"This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study will evaluate the safety and tolerability of HS-20152, an investigational therapy targeting the complement pathway, in healthy adults. Secondary objectives include characterization of pharmacokinetics and pharmacodynamic effects on complement-related biomarkers.",[445],"Healthy Volunteers",[447],"HS-20152; Phase 1; Healthy volunteers","2026-03-25",{"date":450,"type":36},"2026-03-31",{"date":452,"type":23},"2026-04-22",{"date":454,"type":23},"2027-07-01",{"name":42,"class":43},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":421,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":24,"phases":466,"briefSummary":467,"conditions":468,"keywords":472,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":158},"100629435","phase-2-efficacy-and-safety-study-of-hs-10542-for-iga-nephropathy-100629435","NCT07474636","Efficacy and Safety Study of HS-10542 for IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy","Inclusion Criteria:\n\n1. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.\n2. Body weight≥35kg, BMI\\\u003C37.5kg\u002Fm2.\n3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years.\n4. 24-hour urine protein excretion≥1.0g\u002F24h, or UPCR≥0.8g\u002Fg at screening and prior to randomization.\n5. eGFR≥30 ml\u002Fmin\u002F1.73m2 at screening and prior to randomization；\n6. A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm\u002Fegg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).\n7. All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.\n8. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n9. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.\n\nExclusion Criteria:\n\n1. Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;\n2. Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria\\>3.5 g\u002Fday and serum albumin\\\u003C3.0 g\u002FdL, with or without edema);\n3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n4. Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);\n5. Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.\n6. Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;\n7. Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n8. Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;\n9. Participants with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;\n10. Participants with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;\n11. Participants had received systemic glucocorticoid therapy, immunosuppressive agents (e.g. mycophenolate mofetil or calcineurin inhibitors), Chinese patent medicines with immunosuppressive properties (e.g. Tripterygium wilfordii tablets), or renin inhibitors within 12 weeks of randomisation. Alternatively, they were assessed by the investigator as potentially requiring such treatments during the study period.\n12. Participants had received treatment with biologics (e.g. telitacicept, atacicept, povetacicept, sibeprenlimab, CD38 monoclonal antibodies), or with budesonide enteric capsules (NEFECON) or cytokine inhibitors, as well as other products related to the complement pathway (e.g. eculizumab, ravulizumab and avacopan), which were not included in the investigational drug of this study within 6 months prior to randomisation, or participants had received iptacopan within 12 weeks prior to randomization;\n13. Participants have a history of gastrointestinal surgery that may significantly affect the absorption, distribution, metabolism or excretion of drugs. Or have a history of severe gastrointestinal disease, or be experiencing symptoms of dysphagia or recurrent vomiting that cause difficulty eating or taking medication.\n14. Participants with poorly controlled severe systemic diseases at screening, including, but not limited to, severe hypertension (SBP≥180 mmHg and\u002For DBP110 mmHg), severe cardiac disease, pulmonary disease, hepatic disease or haematological disorders, which significantly increase the participant's safety risk as assessed by the investigator;\n15. Participants with a history of tuberculosis, or who have current symptoms, signs, imaging or laboratory evidence of active tuberculosis, or who have a positive IGRA tuberculosis infection screening test result (except the participants who have medical documented evidence of having received standardized preventive anti-tuberculosis treatment within the 5 years prior to screening);\n16. ALT or AST or total bilirubin levels\\>3×ULN at screening;\n17. Hb\\\u003C90 g\u002FL or PLT\\\u003C80×109\u002FL at screening;\n18. HBsAg positive; or HBsAg negative but HBcAb positive with HBV-DNA quantitative results exceeding the ULN defined by the local lab; HCV antibody positive with HCV-RNA quantitative results exceeding the ULN defined by the local lab; HIV antibody positive;\n19. HBA1C≥9.0% at screening;\n20. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or in any drug clinical trial within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or who participated in a clinical trial of oligonucleotide drugs within 1 year prior to randomization;\n21. Women who are pregnant or breastfeeding prior to randomization;\n22. Drug or alcohol abuse within 6 months prior to randomization;\n23. Any illness or condition that the investigator deems likely to increase the risk of the trial, affect participants adherence to the protocol or prevent them from completing it.","74 Years",{"count":465,"type":23},90,[120],"This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.",[469,470,471],"IgAN","Immunoglobulin A Nephropathy (IgAN)","Glomerular Disease",[469,473,421],"Immunoglobulin A Nephropathy","2026-03-11",{"date":476,"type":36},"2026-03-16",{"date":478,"type":23},"2026-03-17",{"date":480,"type":23},"2028-01-30",{"name":42,"class":43},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":505},"100628992","phase-1-a-study-of-hs-10566-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer-who-are-ineligible-for-or-refuse-radical-cystectomy-100628992","NCT07468851","A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","A Phase I\u002FII Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","Inclusion Criteria:\n\n1. Men or women aged greater than or equal to (≥) 18 years.\n2. Signed informed consent form.\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.\n4. Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:\n\n   1. Patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy after prior TURBT, and who refuse or are ineligible for radical cystectomy. BCG unresponsive is defined as occurrence of any one of the following in NMIBC patients after adequate BCG therapy (at least 5 full dose inductions and at least 2 maintenance instillations of BCG):\n\n      * Persistent or recurrent CIS within 12 months after adequate BCG therapy, with or without recurrence of high-grade Ta or T1 tumors;\n      * Recurrence of high-grade Ta\u002FT1 tumors within 6 months after adequate BCG therapy (disease-free);\n      * Recurrence of high-grade tumors at the first assessment during maintenance therapy after adequate BCG induction.\n   2. Patients who have not received BCG therapy after prior TURBT, including the following three scenarios:\n\n      * NMIBC patients who failed intravesical chemotherapy, and who refuse or are ineligible for repeat postoperative intravesical chemotherapy or BCG instillation by the investigator.\n      * HR-NMIBC patients who have not received BCG therapy after TURBT, and who refuse or are ineligible for BCG instillation as determined by the investigator. Ineligibility for BCG includes, but is not limited to: active tuberculosis, severe hematuria, recent traumatic catheterization, symptomatic urinary tract infection, immunodeficiency or impairment (e.g., AIDS, patients receiving immunosuppressants or radiotherapy), BCG hypersensitivity, etc.\n      * HR-NMIBC patients who received prior BCG therapy but discontinued treatment for more than 3 years before enrollment.\n5. Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:\n\n   1. For papillary lesions (Ta and T1 stages): complete resection of all visible papillary lesions, with negative urine cytology (including atypical findings).\n   2. For patients with CIS: residual unresectable CIS lesions are permitted.\n6. Sufficient bone marrow reserve and adequate hepatic\u002Frenal function.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.\n2. Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for \\> 2 years.\n3. History of other primary solid tumors, except:\n\n   1. Radically treated solid tumor with no activity for ≥5 years before enrollment and low recurrence risk;\n   2. adequately treated non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) or lentigo maligna with no evidence of recurrence;\n   3. adequately treated carcinoma in situ (e.g., cervical, ductal carcinoma in situ of breast) with no evidence of recurrence.\n4. Has received or is receiving any of the following treatments:\n\n   1. Regular intravesical chemotherapy (gemcitabine, pirarubicin, mitomycin, etc.) or BCG instillation intolerance following TURBT\u002Fbladder biopsy before enrollment.\n   2. Pelvic radiotherapy within 4 weeks prior to first study treatment. Patients with last radiotherapy \\>4 weeks prior and no confirmed radiation cystitis may be enrolled.\n   3. Major surgery (TURBT is not considered major surgery) within 4 weeks before first study treatment, or incomplete recovery from postoperative complications.\n   4. Systemic chemotherapy, small-molecule targeted therapy, or investigational therapy within 4 weeks before first study treatment.\n5. Residual toxicity ≥ Grade 2 per CTCAE version 6.0 from prior therapy (surgery, intravesical instillation, etc.), except alopecia, pigmentation.\n6. Bladder or urethral anatomical features that may interfere with HS-10566 implantation, retention, or removal (e.g., urethral stricture, bladder diverticulum, total urinary incontinence, bladder perforation).\n7. Current or history of clinically significant polyuria (24-hour urine output \\>4000 mL).\n8. Requirement for long-term indwelling urinary catheter during study treatment (e.g., urinary obstruction).\n9. Intermittent catheterization for clinical indications is allowed.",{"count":490,"type":23},180,[26,120],"This is a multicenter, open-label, Phase I\u002FII clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.",[494],"High-risk Non-muscle-invasive Bladder Cancer",[496],"High-risk Non-muscle-invasive Bladder Neoplasms Administration, Intravesical","2026-03-08",{"date":499,"type":36},"2026-03-13",{"date":501,"type":23},"2026-06-10",{"date":503,"type":23},"2029-04-30",{"name":42,"class":43},2,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":344,"enrollmentInfo":513,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":4},"100624847","phase-1-a-phase-ib-study-of-hs-10504-combined-therapy-in-nsclc-100624847","NCT07414953","A Phase Ib Study of HS-10504 Combined Therapy in NSCLC","A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment；\n* Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment；\n* With at least 1 target lesion according to RECIST 1.1.\n* Appropriate organ function\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.\n* Minimum expected survival longer than 12 weeks\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.\n* Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.\n\nExclusion Criteria:\n\n* Insufficient wash out duration of prior systemic anticancer therapy\n* Local radiotherapy within 2 weeks prior to first dose of investigational drug\n* Pleural\u002Fabdominal effusion requires clinical intervention\n* Major surgery within 4 weeks prior to first dose of investigational drug\n* History of drugs may prolong QT interval\n* Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).\n* Presence of brain metastasis or carcinomatous meningtitis\n* History of other primary malignancies\n* Significant, uncontrolled, or active cardiovascular diseases\n* Severe or poorly controlled diabetes\n* Extremely obesity or emaciation\n* Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose\n* Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose\n* Severe infection within 4 weeks\n* History of systemic glucocorticoids over 28 days prior to first dose of investigational drug\n* Presence of known active infectious diseases,\n* Presence of hepatic encephalopathy, Hepantorenal Syndrome\n* Presence or history of confirmed or suspected ILD;\n* Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.\n* Past history of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.\n* Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.",{"count":514,"type":23},400,[26],"This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).",[518],"Lung Cancer",{"date":520,"type":36},"2026-02-17",{"date":522,"type":23},"2026-03-30",{"date":524,"type":23},"2028-11-30",{"name":42,"class":43},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":424,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":158},"100551520","phase-1-a-study-of-hs-10504-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancernsclc-100551520","NCT06461156","A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10504 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC）","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Progressive disease on or after prior treatment with EGFR-TKIs.\n* Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.\n* At least 1 target lesion according to RECIST 1.1.\n* ECOG PS score: 0-1.\n* Estimated life expectancy\\> 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Women must have the evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Subjects with known oncogenic driver genes other than EGFR.\n* Subjects with mixed cell histologic or with phenotypic transformation.\n* Treatment with any of the following:\n\n  1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.\n  2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.\n  3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose\n  4. Uncontrolled pleural effusion or ascites or pericardial effusion.\n  5. Major surgery within 4 weeks before the first dose.\n  6. CNS metastases with symptomatic or active progression.\n* Subjects who have any grade ≥2 residual toxicities from prior therapies.\n* Subjects who have history of other primary malignancies.\n* Inadequate bone marrow reserve or hepatic and renal functions.\n* Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.\n* Hypersensitivity to any ingredient of HS-10504.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.",{"count":534,"type":23},230,[26],"HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.",[538],"Locally Advanced or Metastatic NSCLC",[540,541,60],"locally advanced or metastatic NSCLC","EGFR C797S","2025-09-11",{"date":544,"type":36},"2025-09-17",{"date":546,"type":36},"2025-07-22",{"date":108,"type":23},{"name":42,"class":43},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":24,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":505},"100604978","phase-3-a-phase-3-study-of-hs-20094-in-patients-with-t2dm-100604978","NCT07156539","A Phase 3 Study of HS-20094 in Patients With T2DM","A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete","Inclusion Criteria:\n\n1. Males and females, Age ≥18 years at the time of signing informed consent.\n2. Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;\n3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;\n4. BMI ≥ 23 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.\n2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.\n3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).\n4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；\n5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.\n6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).",{"count":557,"type":23},546,[144],"The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.",[561],"Type 2 Diabetes","2025-08-28",{"date":564,"type":36},"2025-09-05",{"date":566,"type":23},"2025-09-30",{"date":568,"type":23},"2027-05-30",{"name":42,"class":43},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":585,"locationsCount":158},"100604975","phase-3-a-phase-3-study-of-hs-20094-in-patients-with-t2dm-inadequately-controlled-with-diet-and-exercise-alone-100604975","NCT07156500","A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone","A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Males and females, Age ≥18 years at the time of signing informed consent.\n2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.\n3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.\n4. 7.5% ≤ HbA1c ≤10.5% at screening.\n\nExclusion Criteria:\n\n1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.\n2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.\n3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).\n4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；\n5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.\n6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).",{"count":578,"type":23},204,[144],"This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.",[561],{"date":564,"type":36},{"date":566,"type":23},{"date":568,"type":23},{"name":42,"class":43},""]