[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643778":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":84,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Ausper Biopharma Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AHB-137","EXPERIMENTAL","AHB-137 will be administered subcutaneously.",[13],"Drug: AHB-137",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo will be administered subcutaneously.",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28,32],{"name":29,"affiliation":30,"role":31},"Yunqing Qiu","Zhejiang University","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Peng Hu","The Second Affiliated Hospital of Chongqing Medical University",[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Lu","CONTACT","0571-86959519","clinicaltrial@ausperbio.com",[42,53],{"facility":34,"status":24,"city":43,"state":44,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":24},"Chongqing","Chongqing Municipality","China","CN",{"type":48,"coordinates":49},"Point",[50,51],106.55771,29.56026,{"lat":51,"lon":50},{"facility":54,"status":24,"city":55,"state":56,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":24},"The First Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":48,"coordinates":58},[59,60],120.16142,30.29365,{"lat":60,"lon":59},{"type":63,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100643778","phase-2-a-study-to-evaluate-ahb-137-injection-in-treatment-nave-participants-with-chronic-hepatitis-b-100643778",false,"NCT07635186","A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.","Inclusion Criteria:\n\n* Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.\n* Aged 18-65 years (including boundary values).\n* Body mass index between the range of 18-32 kg\u002Fm2 (inclusive boundary values).\n* HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.\n* HBsAg and HBV DNA values met protocol requirements at screening.\n* ALT \\\u003C 3xULN at screening.\n* Use highly effective contraception as required.\n\nExclusion Criteria:\n\n* Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.\n* Participants with other clinically significant liver diseases, previous\u002Fcurrent manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.\n* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.\n* Hepatitis C virus (HCV) infection or \\\u003C 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).\n* Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \\> 9.0 kPa at screening.\n* Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.\n* Laboratory test results do not meet the criteria.\n* Prior\u002Fcurrent autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.\n* Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.\n* Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.\n* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.\n* Participants are participating in another clinical trial or failing to wash out as required.\n* Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical\u002Finhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.\n* Participants that require regular long-term anticoagulants.\n* Abnormal thyroid function.\n* Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.\n* Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.","ALL","18 Years","65 Years",{"count":75,"type":76},320,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.",[82],"Chronic Hepatitis B",[82],"NOT_YET_RECRUITING","2026-06-03",{"date":87,"type":88},"2026-06-09","ACTUAL",{"date":90,"type":76},"2026-06-20",{"date":92,"type":76},"2028-06-20",{"name":5,"class":6},2]