[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Zenshine Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100649240","phase-3-study-to-assess-the-prophylactic-efficacy-and-safety-of-sebaloxavir-marboxil-tabletsoral-suspension-for-influenza-prevention-in-household-contacts-aged-2-years-100649240",false,"NCT07730346","Study to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets\u002FOral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets\u002FOral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.","Index Participants:\n\nInclusion Criteria：\n\n* 1\\. The index participant (aged ≥18 years), or the index participant (aged \\\u003C18 years) together with their legal guardian, understands and voluntarily provides written informed consent form (ICF). The index participant must be ≥1 year of age at the time of ICF signing, with no gender restriction.\n* 2\\. The index participant must be the first case of influenza virus infection in the household during the current influenza season.\n* 3\\. The index participant must have a positive result from a rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) assay.\n* 4\\. At the time of HHC randomization, the interval from the onset of the index participant's initial influenza symptoms to informed consent must be ≤48 hours. Symptom onset is defined as: first axillary temperature ≥37.5°C, or the presence of at least one other influenza symptom.\n* 5\\. The index participant must not have used any anti-influenza antiviral medications (including traditional Chinese medicines or Western medicines) since symptom onset, and must be willing to receive oseltamivir phosphate treatment after signing informed consent form.\n\nExclusion Criteria：\n\n* 1\\. Participants who are diagnosed with bacterial or other non-influenza virus infections at screening requiring systemic antibacterial or antiviral treatment;\n* 2\\. Participants with suspected hypersensitivity to the active ingredients or excipients of oseltamivir phosphate oral suspension\u002Fcapsules.\n\nHousehold contact:\n\nInclusion Criteria：\n\n* 1\\. Aged ≥2 years at the time of randomization, with no gender restriction;\n* 2\\. Has been living in the same household with the index participant for at least 48 hours at the time of randomization;\n* 3\\. Is able to reside with the index participant from screening\u002Frandomization through Day 10 (must live in the same household with the index participant for at least 7 days);\n* 4\\. Tests negative by rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR);\n* 5\\. Meets all of the following criteria and is judged by the investigator to have no influenza virus infection:\n\n  1. Axillary temperature \\\u003C37°C at screening;\n  2. No influenza-related symptoms at screening (such as nasal congestion, sore throat, cough, myalgia or arthralgia, fatigue, headache, chills\u002Fsweating, or other influenza symptoms assessed by the investigator);\n* 6\\. The HHC is ≥18 years of age, or the HHC is \\\u003C18 years of age and together with their parent(s)\u002Flegal guardian(s) understands and voluntarily signs the informed consent form (ICF), and agrees to comply with all study procedures, including completion of diary cards (the guardian may assist in assessment\u002Fcompletion).\n* 7\\. The HHC must sign the informed consent form (ICF) within 24 hours after the index participant signs the ICF;\n* 8\\. The HHC and their partner must agree to practice complete abstinence or use effective contraceptive measures from screening through 3 months after the end of study drug administration.\n\nExclusion Criteria：\n\n* 1\\. Participants with suspected hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational product;\n* 2\\. Participants whose household contacts or other family members (excluding the index participant) have been diagnosed with influenza within 3 months before randomization;\n* 3\\. Participants who have been cohabiting with other family members exhibiting influenza-like symptoms (axillary temperature ≥37.5°C, nasal congestion, sore throat, cough, myalgia\u002Farthralgia, fatigue, headache, chills\u002Fsweating, or other influenza symptoms as assessed by the investigator) other than on the screening day;\n* 4\\. Participants requiring systemic (oral or injectable) or intranasal antipyretic\u002Fanalgesic agents, corticosteroids, or immunosuppressants (those using topical preparations are allowed);\n* 5\\. Participants who have received an influenza vaccine within 6 months prior to screening;\n* 6\\. Participants who have taken anti-influenza Chinese or Western medications within 30 days prior to screening, including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, cap-dependent endonuclease (CEN) inhibitors, and heat-clearing\u002Fdetoxifying Chinese herbal medicines, such as oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, rimantadine, amantadine, arbidol, nitazoxanide, baloxavir, Lianhua Qingwen capsules\u002Fgranules, Jinhua Qinggan granules\\*, etc.\n* 7\\. Participants with active infection or requiring systemic anti-infective treatment at screening (topical therapy for mild skin infections is allowed).\n* 8\\. Participants with other respiratory viral infections.\n* 9\\. Participants with difficulty swallowing study medication or a history of gastrointestinal disorders that may significantly impair drug absorption, including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, or post-gastrectomy.\n* 10\\. Participants with severe underlying comorbidities, defined as Grade 3 or higher per the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.\n* 11\\. Immunocompromised participants, including those with malignancies, history of organ or bone marrow transplantation, HIV infection, or use of immunosuppressants within the previous 3 months.\n* 12\\. HHCs requiring long-term use of aspirin- or salicylate-containing products, defined as daily regular use for more than 14 consecutive days.\n* 13\\. Participants with suspected or confirmed alcohol abuse (defined as weekly consumption of \\>14 units of alcohol; 1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL of 12% wine) or history of drug abuse.\n* 14\\. Participants who have participated in another interventional clinical trial of a drug or medical device within 30 days before screening.\n* 15\\. Women who have a positive pregnancy test result or are currently lactating.\n* 16\\. Participants with any other conditions that, in the judgment of the investigator, would preclude enrollment in the study.",true,"ALL","2 Years",{"count":20,"type":21},858,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a randomized, double-blind, placebo-controlled phase III clinical trial. The trial participants include index participants (IP) and household contacts (HHC). A total of 536 index participants (the first person in the household diagnosed with influenza) and 858 household contacts (family members living with the index participant) are planned to be enrolled. After the index participants and their household contacts have signed informed consent form and passed screening eligibility, randomization will be performed at the household level in a 1:1 ratio, stratifying by the time from onset of the index participant's initial influenza symptoms to signing of informed consent form (\\\u003C24 hours, ≥24 hours), index participant's viral subtype (influenza A, influenza B), and household contact's age (\\\u003C12 years, ≥12 years). Household contacts will be assigned to either the Sebaloxavir marboxil group or the placebo group. The study objective is to compare the prophylactic efficacy and safety of Sebaloxavir marboxil tablets\u002Foral suspension versus placebo in household contacts (HHCs).",[27],"Influenza Prevention","NOT_YET_RECRUITING","2026-07-23",{"date":31,"type":32},"2026-07-28","ACTUAL",{"date":34,"type":21},"2026-11-07",{"date":36,"type":21},"2028-01-30",{"name":38,"class":39},"Nanjing Zenshine Pharmaceuticals","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100616786","phase-1-study-to-evaluate-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-of-zx-8177-in-patients-with-advanced-solid-tumors-100616786","NCT07310134","Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Dose Escalation and Dose Expansion of ZX-8177 Tablets in Chinese Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in this clinical trial, understand and comply with the study procedures, and voluntarily sign the Informed Consent Form (ICF).\n* 2\\. No gender restriction, age ≥ 18 years at the time of signing ICF.\n* 3\\. Minimum expected survival period ≥ 3 months (as determined by the investigator's assessment).\n* 4\\. ECOG score is 0-1.\n* 5\\. Advanced malignant tumors confirmed by histology\u002Fcytology: Advanced solid tumors without standard effective treatment options, or those that are ineffective or recurrent after standard treatment, or intolerant to standard treatment, or for which standard treatment is not applicable at this stage.\n* 6\\. The subject must have at least one measurable lesion defined by RECIST v1.1, which has not been previously irradiated or has shown clear disease progression after radiotherapy.\n* 7.Adequate Organ Function:\n\n  1. Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin \\[Cockcroft-Gault formula: (\\[140 - age\\] × weight \\[kg\\] × \\[0.85 for females only\\]) \u002F (72 × creatinine (mg\u002Fdl))\\]; qualitative urine protein ≤ 1+; if qualitative urine protein ≥ 2+, a 24-hour urine protein quantification test is required, and a result of \\\u003C1 g is acceptable.\n  2. Hepatic: AST and ALT ≤ 2.5 × ULN (for subjects with liver involvement, AST and ALT ≤ 4 × ULN); total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin ≤ 3 × ULN). Coagulation function: For subjects not receiving anticoagulant therapy, the International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.\n  3. Bone Marrow: Absolute neutrophil count (ANC) \\> 1.5 × 10⁹\u002FL; hemoglobin level ≥ 90 g\u002FL; platelet count ≥ 90 × 10⁹\u002FL (administration of medications with leukocyte\u002Fplatelet-boosting effects within 14 days prior to enrollment to meet eligibility criteria is not permitted).\n* 8\\. Female patients of childbearing potential must have a negative serum pregnancy test during screening. Female patients not of childbearing potential (meeting at least one of the following criteria):\n\n  1. Have undergone hysterectomy or bilateral oophorectomy\u002Fsalpingectomy, or\n  2. Have medically confirmed ovarian failure, or\n  3. Are medically confirmed to be physiologically postmenopausal (with amenorrhea for at least 12 consecutive months, excluding causes such as chemotherapy, radiotherapy, or the use of estrogen\u002Fprogestin therapy or other pathological factors).\n* 9\\. Females of childbearing potential and male partners of females of childbearing potential must agree to use effective contraception during the study and for 6 months (for females) or 3 months (for males) after the last dose of ZX-8177:\n\n  1. Including prescription hormonal oral contraceptives, contraceptive injections, contraceptive patches, vaginal rings, intrauterine devices, barrier methods (e.g., condoms, diaphragms, or cervical caps), or spermicidal foams, creams, or gels, or\n  2. Practice complete abstinence, or\n  3. The sole sexual partner of a female of childbearing potential is a male who has been confirmed sterile.\n* 10\\. Males must agree to avoid sperm donation during the study and for 3 months after the last dose of ZX-8177.\n\nExclusion Criteria:\n\n* 1\\. Previous use of ENPP1 inhibitors or STING agonists.\n* 2\\. Received anti-tumor drug treatment within 28 days prior to the first administration of the study drug (including small-molecule targeted drugs, oral fluorouracil-based chemotherapy drugs, or modern traditional Chinese medicine preparations approved by the National Medical Products Administration (NMPA) for anti-tumor therapy within 14 days; mitomycin C or nitrosourea-based chemotherapy drugs within 6 weeks), excluding bisphosphonates for bone metastases.\n* 3\\. History of immune-related adverse events (irAEs) of grade ≥3 during previous immunotherapy.\n* 4\\. Undergone radiotherapy within 14 days prior to the first administration of the study drug; palliative radiotherapy for the purpose of alleviating local symptoms (non-target lesion irradiation or local administration to non-target lesions) completed within one week before study enrollment is allowed.\n* 5\\. Participation in any other interventional clinical trials within 1 month prior to enrollment or within less than 5 half-lives (except for subjects who have completed other clinical studies and are only undergoing subsequent survival follow-up).\n* 6\\. History of any organ transplantation, including allogeneic stem cell transplantation, except for transplants that do not require immunosuppression (e.g., corneal transplantation, hair transplantation).\n* 7\\. Major surgery requiring general anesthesia, liver ablation, or hepatic arterial intervention within 28 days before the first administration of the investigational drug; or surgery requiring local\u002Fepidural anesthesia within 2 weeks prior to starting the investigational drug; or the subject has planned surgery or is considered by the investigator to require surgery; or unresolved postoperative complications before dosing (major surgery is defined as procedures under general anesthesia or involving significant incisions);\n* 8\\. Adverse reactions from prior anti-tumor therapy or complications\u002Fsequelae from surgery \\> Grade 1 or not resolved to baseline (CTCAE v5.0, except alopecia or other toxicities deemed by the investigator to pose no safety risk to the subject);\n* 9\\. Administration of live, inactivated, or attenuated vaccines within 30 days before the first dose of the investigational drug; examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, COVID, bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated or attenuated vaccines such as injectable seasonal influenza vaccines, intranasal influenza vaccines (e.g., FluMist®), etc.;\n* 10\\. Subjects with symptomatic central nervous system metastases or carcinomatous meningitis (including leptomeningeal carcinomatosis); if CNS metastases are present, they must be assessed by the investigator as asymptomatic and stable for at least 3 months.\n* 11\\. History of another malignancy within the past 5 years, except malignancies treated with surgery alone and in continuous disease-free survival; except early-stage in situ carcinoma after resection;\n* 12\\. Uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypomagnesemia, hypokalemia);\n* 13\\. Dysphagia;\n* 14\\. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites;\n* 15\\. Systemic use of immunosuppressive doses (prednisone \\>10 mg\u002Fday or equivalent) of medications (e.g., corticosteroids) within 2 weeks before starting the investigational drug, excluding topical glucocorticoids via nasal spray, inhalation, or other local routes, or physiological doses of systemic glucocorticoids (i.e., not exceeding 10 mg\u002Fday prednisone or equivalent of other glucocorticoids);\n* 16\\. Clinically significant active cardiac disease or history, including but not limited to any of the following:\n\n  1. History of long QT syndrome or confirmed family history of long QT syndrome;\n  2. History of clinically significant ventricular arrhythmias;\n  3. History of unstable angina, acute myocardial infarction, coronary artery bypass grafting, or symptomatic congestive heart failure within 6 months before enrollment;\n  4. Current implantable defibrillator or pacemaker for ventricular arrhythmias;\n  5. Known concomitant medications required that prolong the QT interval;\n  6. Baseline QTcF interval corrected by Fridericia's formula \\>450 msec (male) or \\>470 msec (female);\n  7. Complete left bundle branch block or complete right bundle branch block with left anterior fascicular block (bifascicular block);\n  8. Left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography;\n  9. Myocardial infarction, bypass, stent surgery, or other cardiac conditions deemed unsuitable for enrollment by the investigator within 6 months before dosing;\n* 17\\. Underlying diseases that may interfere with study evaluation, such as:\n\n  1. Poorly controlled hypertension (defined as resting systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥95 mmHg despite treatment with two or more antihypertensive agents of different mechanisms);\n  2. Baseline hemoglobin A1c \\>8.0%;\n* 18\\. Active infection, including clinically uncontrolled active infectious diseases within 14 days before enrollment such as acute pneumonia, unexplained persistent fever, etc.; or meeting any of the following criteria: a) Positive human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome; b) Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBsAg positive with HBV DNA copies above the upper limit of normal, or HCV-Ab positive; c) Active tuberculosis (history of exposure or positive tuberculin test; accompanied by clinical and\u002For imaging manifestations); d) Positive treponemal antibody; e) Cytomegalovirus (CMV) infection, etc.\n\nNote: Subjects with positive HBsAg and\u002For HBcAb who are stable after medication (HBV-DNA \\\u003C500 IU\u002FmL) and cured hepatitis C subjects (HCV-RNA PCR negative in patients with known HCV history within \\\u003C6 months before starting ZX-8177) may be enrolled. Virological monitoring is required before dosing on Day 15 of Cycle 1 and before dosing on Day 1 of each subsequent cycle. Prophylactic antiviral therapy may be considered based on the subject's condition.\n\n* 19\\. Known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cholangitis, persistent extrahepatic obstruction due to gallstones, cirrhosis, or portal hypertension;\n* 20\\. Severe lung disease (history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm);\n* 21\\. Gastrointestinal dysfunction that may limit absorption of the investigational drug, including motility disorders, malabsorption syndromes, inflammatory bowel disease, chronic diarrhea, Crohn's disease, and\u002For prior surgery affecting absorption;\n* 22\\. Psychiatric disorders or substance abuse;\n* 23.Pregnant or breastfeeding women;\n* 24\\. Allergic constitution or history of severe allergies;\n* 25\\. Intolerance to venipuncture;\n* 26\\. History of autoimmune disease, or active, known, or suspected autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune vasculitis, thyroid disorders, or glomerulonephritis). Subjects with the following conditions may be enrolled: vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement, or conditions not expected to recur in the absence of external triggers;\n* 27\\. Expected receipt of other systemic anti-tumor therapy during the study;\n* 28\\. The patient is currently taking known inhibitors of OATP1B1, OATP1B3, and OAT3 and cannot discontinue use within 1 week before starting the investigational drug (or within 5 half-lives of the drug, whichever is longer) and during the study;\n* 29\\. Any other condition considered by the investigator to be unsuitable for enrollment.","18 Years",{"count":50,"type":21},80,[52],"PHASE1","This study is an open-label, multicenter, phase I clinical trial involving dose escalation and dose expansion of ZX-8177 in patients with advanced unresectable, recurrent, or metastatic solid tumors.\n\nThe study consists of two stages: dose escalation and dose expansion. It primarily aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and preliminary efficacy of ZX-8177 as a monotherapy with continuous administration in Chinese patients with advanced solid tumors who have failed standard treatment or lack standard treatment options. The study also seeks to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD)\u002Foptimal biological dose (OBD), or recommended phase II dose (RP2D).",[55],"Advanced Solid Tumors",[57],"advanced solid tumors","RECRUITING","2025-12-29",{"date":61,"type":32},"2026-01-02",{"date":63,"type":32},"2025-12-26",{"date":65,"type":21},"2026-12-30",{"name":38,"class":39},""]