[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":202},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,63,88,114,134,156,181],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100649565","phase-1-a-study-of-hw243040-in-healthy-participants-100649565",false,"NCT07737496","A Study of HW243040 in Healthy Participants","A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants","Inclusion Criteria:\n\n* Informed consent must be obtained\u002Fsigned prior to trial participation.\n* Aged between 18 and 55 years old, both healthy males and females are eligible.\n* Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n* History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections.\n* History of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps).\n* Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and\u002For excretion of the investigational product.\n* History of drug abuse or dependence.\n* Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis.\n* Any other condition that, in the opinion of the investigator, renders the participant unsuitable to participate in the study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},98,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.",[28],"Healthy","NOT_YET_RECRUITING","2026-07-29",{"date":32,"type":33},"2026-07-31","ACTUAL",{"date":35,"type":22},"2026-08-10",{"date":37,"type":22},"2027-05-31",{"name":39,"class":40},"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100648331","phase-1-a-phase-iaib-study-of-hw221043-in-participants-with-advanced-solid-tumors-100648331","NCT07719920","A Phase Ia\u002FIb Study of HW221043 in Participants With Advanced Solid Tumors","A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Men or women ≥18 years old.\n* Histologically and\u002For cytologically confirmed recurrent or metastatic advanced solid tumors.\n* Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.\n* Survival expectation is ≥12 weeks.\n* Adequate major organ function at screening; no blood transfusion or hematopoietic growth factor administration within 14 days prior to screening; and no significant abnormalities in hematology, coagulation profiles, or blood chemistry.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Presence of at least one measurable target lesion as defined by RECIST 1.1\n* Participants are willing to provide tumor tissue samples.\n* Participants of childbearing potential must be non-pregnant at screening. Male and female of childbearing potential must agree to use effective methods of contraception throughout the study.\n* Participants must have demonstrated a full understanding of the study, voluntarily signed the informed consent form (ICF), and be willing and able to comply with all study procedures and required follow-up visits.\n\nExclusion Criteria:\n\n* Allergic to HW221043 Tablet or its components.\n* Has a treatment history of KIF18A inhibitor.\n* Known presence of a recognizable hypermutated phenotype.\n* Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.\n* Inadequate washout from prior antitumor therapy.\n* Use of any medication that may interfere with the safety conduct of the study within 14 days prior to the first dose (or within at least 5 half-lives of the agent, whichever is longer), or planned use of such medications during the study period.\n* Continuous use of systemic corticosteroids within 4 weeks prior to the first dose.\n* Live vaccination within 28 days prior to first dose or anticipated during the study.\n* Major surgery within 28 days prior to the first dose of the investigational product.\n* Major surgical procedure within 28 days prior to first dose.\n* History of another active malignancy within 3 years prior to initiation of the investigational product.\n* ≥ Grade 2 prior antitumor therapy-related toxicity per CTCAE v6.0 (except abnormalities deemed clinically insignificant).\n* Tumor invasion into adjacent vital organs, major vessels, or central nervous system (CNS), or evidence of progressive brain metastases.\n* Presence of severe underlying pulmonary disease, severe cardiac\u002Fcerebrovascular disease, or clinically significant QTc prolongation.\n* Presence of an active infectious disease.\n* Diagnosis of an autoimmune disease or presence of an immunodeficient state.\n* Inability to swallow oral medications, or uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal dysfunction likely to affect drug absorption.\n* History of alcohol abuse or substance abuse.\n* Women who are pregnant, breastfeeding, or planning to become pregnant\u002F breastfeeding during the study.\n* Any condition that, in the judgment of the Investigator, would make the participant unsuitable for enrollment.",{"count":50,"type":22},99,[25],"This is a Phase Ia\u002FIb, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).",[54],"Advanced Solid Tumors","2026-07-17",{"date":57,"type":33},"2026-07-22",{"date":59,"type":22},"2026-07-30",{"date":61,"type":22},"2029-12-31",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100632420","phase-2-a-phase-2-study-of-hw211026-100632420","NCT07513454","A Phase 2 Study of HW211026","A Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.","Key Inclusion Criteria:\n\n* Aged ≥ 18 years, male or female.\n* 2 to 8 clinically typical target actinic keratosis lesions on the face.\n* Willing to avoid direct sun or ultraviolet exposure to the treatment area during the trial.\n* Fully informed about the study, voluntarily sign the informed consent form, and be able to comply with study procedures and follow-up examination requirements.\n\nKey Exclusion Criteria:\n\n* Target lesions with any of the following conditions: 1) Clinically atypical and\u002For rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and\u002For cutaneous horns. 2) Maximum diameter of a single lesion \\> 2 cm. 3) Concurrent invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma or other malignant tumors. 4) Other skin diseases or skin conditions that may interfere with examination or lesion assessment.\n* Presence of incompletely healed wounds or suspected squamous cell carcinoma, basal cell carcinoma, or other malignant tumors within 5 cm of the actinic keratosis lesions.\n* Participants with other skin diseases or skin conditions that, in the investigator's judgment, may interfere with the evaluation of safety or efficacy.\n* Participants who have undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial, as determined by the investigator.\n* Participants who have participated in any investigational drug clinical trial and received an investigational product within 3 months prior to screening.",{"count":71,"type":22},80,[73],"PHASE2","This is a multicenter, randomized, open-label, parallel-group, Phase II clinical trial designed to evaluate the efficacy and safety of HW211026 in adult patients with actinic keratosis.",[76],"Actinic Keratosis",[78,79],"HW211026","actinic keratosis","2026-07-07",{"date":82,"type":33},"2026-07-09",{"date":84,"type":22},"2026-07",{"date":86,"type":22},"2027-12",{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":41},"100640559","phase-1-a-phase-i-study-of-hw241045-in-healthy-subjects-100640559","NCT07593690","A Phase I Study of HW241045 in Healthy Subjects","A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HW241045 Tablets After Single and Multiple Dosing in Healthy Study Participants.","Key Inclusion Criteria:\n\n* The study participant is able to communicate well with the investigator, understand and comply with all requirements of the study, fully comprehend the purpose, nature and methodology of the trial as well as potential adverse reactions, and sign the informed consent form prior to initiation of any study procedures.\n* Healthy male and female study participants aged 18 to 45 years (inclusive).\n* Female study participants shall have a body weight ≥ 45 kg, male study participants ≥ 50 kg; body mass index (BMI) ranges from 19 to 26 kg\u002Fm² (inclusive).\n\nKey Exclusion Criteria:\n\n* Any study participant with a past or current clinically severe or chronic disease involving the circulatory, endocrine, nervous, digestive, respiratory, hematologic, or immune system, as well as psychiatric disorders and metabolic abnormalities; or with any other disease deemed by the investigator likely to interfere with the trial results.\n* Participants with a history of gastrointestinal, hepatic or renal diseases that may affect drug absorption or metabolism, or with known or suspected diseases that may interfere with drug intake, transportation, absorption, distribution, metabolism or excretion.\n* Participants with a history of drug or food allergy, allergic diseases, or allergic constitution (allergic to two or more substances), or with a confirmed allergy to any component of the study drug.\n* Participants who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days prior to the trial or during the trial period.\n* Participants with any other factors deemed unsuitable for participation in the clinical study by the investigator.","45 Years",{"count":97,"type":22},102,[25],"This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW241045 in healthy participants.\n\nThis study consists of three parts:1）Part A: A single-dose, two-period, two-way crossover design to evaluate the safety and pharmacokinetic differences between Formulation A and Formulation B of HW241045 tablets; 2）Part B: A single-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B following single administration. A food-effect study is nested within this part.3）Part C: A multiple-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B after multiple administrations.",[101],"Idiopathic Pulmonary Fibrosis (IPF)",[103,104,105],"HW241045","Idiopathic Pulmonary Fibrosis","healthy participants","2026-05-12",{"date":108,"type":33},"2026-05-18",{"date":110,"type":22},"2026-06",{"date":112,"type":22},"2027-01",{"name":39,"class":40},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":41},"100630850","phase-1-a-phase-study-of-hw252001-in-healthy-subjects-100630850","NCT07493031","A PhaseⅠ Study of HW252001 in Healthy Subjects","A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects","Inclusion Criteria:\n\n* The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.\n* Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.\n* During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) \u002F height² (m²), and must be within the range of 19 kg\u002Fm² to 26 kg\u002Fm².\n\nExclusion Criteria:\n\n* Subjects with a history of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps);\n* Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and\u002For excretion of the study drug.\n* Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.\n* Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.\n* Subjects with a positive result for any of the following at screening: Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus antibody.\n* Subjects with a history of heavy smoking (averaging \\>5 cigarettes per day) within 4 weeks prior to screening or baseline, or those unable to discontinue the use of any tobacco products during the trial period.\n* Subjects with an average daily alcohol intake exceeding 15g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol liquor) within 4 weeks prior to the screening or baseline period; or those unable to abstain from alcohol during the trial; or those with a positive breath alcohol test at baseline.\n* Subjects with a history of drug abuse or drug dependency prior to screening or baseline; or those with a positive urine drug test at baseline.\n* Subjects who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (averaging more than 8 cups per day, 250 mL per cup) within 48 hours prior to the first dose.\n* Subjects with specific dietary requirements who are unable to comply with the unified diet.\n* Subjects allergic to any component of the study drug; or those with a history of allergic diseases or a predisposition to allergies.\n* Subjects with dysphagia, difficulty with venous blood collection, or physical conditions that cannot tolerate intensive blood sampling.\n* Subjects judged by the investigator as unsuitable to participate in this trial for any other reason.",{"count":21,"type":22},[25],"This is a phase 1, randomized, double-blind, placebo-controlled, Single\u002Fmultiple ascending doses (SAD\u002FMAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.",[125],"IPF","2026-03-24",{"date":128,"type":33},"2026-03-27",{"date":130,"type":22},"2026-03-31",{"date":132,"type":22},"2026-12-11",{"name":39,"class":40},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100630116","phase-2-a-phase-2-study-of-hw091077-in-participants-with-refractory-chronic-cough-or-unexplained-chronic-cough-rccucc-100630116","NCT07483489","A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC\u002FUCC).","A Randomized，Double-Blind, Multicenter，Placebo-Controlled, Parallel-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of HW091077 in Participants With Refractory Chronic Cough or Unexplained Chronic Cough (RCC\u002FUCC).","Inclusion Criteria:\n\n* Aged between 18 and 80 years;\n* Diagnosed with refractory chronic cough or unexplained chronic cough, with a cough lasting for ≥1 year;\n* Chest CT at screening shows no abnormalities that the investigator believes may lead to chronic cough;\n* Cough severity VAS score ≥40 mm ;\n* Female participants of childbearing potential must have a negative pregnancy test and must not be breastfeeding; male and female participants must have no plans for pregnancy during the entire clinical trial and within 6 months after the last dose, and agree to use medically accepted reliable contraceptive methods during the trial and within 6 months after the last dose;\n* Fully understand the study, voluntarily sign the informed consent form, and be able to comply with the study procedures and follow-up requirements.\n\nExclusion Criteria:\n\n* Currently smoking, or having quit smoking within 12 months prior to screening;\n* A smoking history of \\>20 pack-years;\n* Ongoing exposure to inhaled toxic substances within 12 months prior to screening or currently;\n* A history of drug abuse or alcoholism (weekly alcohol consumption of 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);\n* Diagnosed with chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, bronchial asthma (except for cough variant asthma), or other airway\u002Frespiratory diseases that may affect coughing;\n* Respiratory tract infection or significant changes in lung status within 4 weeks prior to screening;\n* FEV1\u002FFVC)\\\u003C60%;\n* Clinically significant electrocardiogram abnormalities, such as QTc interval ≥450 ms, long QT syndrome, etc.;\n* Use of angiotensin-converting enzyme inhibitors (ACEIs) within 3 months prior to screening;\n* Plans to initiate new treatment for RCC\u002FUCC during the trial period;\n* Taste disturbance within 1 month prior to screening;\n* Use of any P2X3 receptor antagonist within 1 year prior to screening;","80 Years",{"count":143,"type":22},180,[73],"This is a randomized, multicenter, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HW091077 in Chinese adult subjects with refractory chronic cough or unexplained chronic cough (RCC\u002FUCC).",[147],"Refractory Chronic Cough","2026-03-16",{"date":150,"type":33},"2026-03-19",{"date":152,"type":22},"2026-05-01",{"date":154,"type":22},"2028-08-30",{"name":39,"class":40},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":180,"locationsCount":41},"100627404","phase-1-a-phase-ia-clinical-trial-of-hw241045-100627404","NCT07448194","A Phase Ia Clinical Trial of HW241045","A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets Following a Single Dose in Healthy Subjects: A Single-center, Randomized, Double-blind, Placebo-controlled Study","Key Inclusion Criteria:\n\n* The subjects have been fully informed of the trial's purpose, nature, methodology, and potential adverse reactions. They voluntarily participate in the trial and sign the informed consent form prior to the initiation of any study procedures;\n* Healthy male and female subjects aged 18 to 55 years;\n* Female subjects must have a body weight of ≥ 45 kg and male subjects ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg\u002Fm².\n\nKey Exclusion Criteria:\n\n* Subjects with a history of or current severe clinical disease involving any of the following systems: circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems; or subjects with any other disease that the investigator judges may interfere with the study results;\n* Subjects with a history of severe trauma or major surgery within 3 months prior to screening; or subjects planning to undergo surgery during the trial period or within two weeks after study completion;\n* Subjects with a history of gastrointestinal, hepatic, or renal diseases that affect drug absorption or metabolism; or those with conditions known or suspected to interfere with drug ingestion, transport, absorption, distribution, metabolism, or excretion;\n* Subjects with clinically significant abnormalities in any screening test results as judged by the investigator;\n* Subjects with a history of drug or food allergy, allergic disorders, or atopic diathesis; or those with confirmed hypersensitivity to any component of the investigational drug;\n* Subjects with difficult venous blood collection, or whose physical condition cannot tolerate intensive blood sampling;\n* Not suitable for this study as judged by the investigator.",{"count":164,"type":22},56,[25],"This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.",[168,125],"Healthy Volunteers",[103,170,171,172],"healthy volunteers","Safety","Pharmacokinetics","RECRUITING","2026-03-03",{"date":176,"type":33},"2026-03-04",{"date":178,"type":33},"2025-11-24",{"date":110,"type":22},{"name":39,"class":40},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":41},"100617442","phase-1-a-phase-ib-study-of-hw211026-ointment-in-patients-with-actinic-keratosis-100617442","NCT07318675","A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.","A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis","Key Inclusion Criteria:\n\n* Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.\n* A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal).\n* Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study.\n\nKey Exclusion Criteria:\n\n* Subjects with any of the following conditions within the treatment field：\n\n  * Presence of clinically atypical and\u002For rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and\u002For cutaneous horns;\n  * Maximum diameter of a single lesion \\> 2 cm；\n  * History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；\n  * Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.\n* treatment field falls within any of the following locations:\n\n  * Presence of incompletely healed wounds within a 5 cm radius of the treatment field;\n  * Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field.\n* Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy.\n* Subjects with severe cardiovascular and cerebrovascular diseases.\n* Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.\n* Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.",{"count":189,"type":22},40,[25],"This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.",[193],"Actinic Keratosis (AK)","2026-01-04",{"date":196,"type":33},"2026-01-06",{"date":198,"type":33},"2025-12-25",{"date":200,"type":22},"2026-03",{"name":39,"class":40},""]