[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632248":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":11,"studyPopulation":11,"armGroups":80,"interventions":93,"overallOfficials":11,"centralContacts":107,"locations":113,"responsibleParty":134,"collaborators":11,"id":136,"slug":11,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":11,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":11,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Ausper Biopharma Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":11},[9,13,15,17,19,22,24,26],{"measure":10,"description":11,"timeFrame":12},"Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)",null,"PartA:Up to 16 weeks, PartB: Up to 48 weeks",{"measure":14,"description":11,"timeFrame":12},"Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)",{"measure":16,"description":11,"timeFrame":12},"Proportion of participants with clinically significant abnormalities in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs",{"measure":18,"description":11,"timeFrame":12},"Change from baseline in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs",{"measure":20,"description":11,"timeFrame":21},"Part A:Plasma Cmax of AHB-171","Up to Day 8",{"measure":23,"description":11,"timeFrame":21},"Part A:Plasma Tmax of AHB-171",{"measure":25,"description":11,"timeFrame":21},"Part A Plasma AUC of AHB-171",{"measure":27,"description":11,"timeFrame":21},"Part A Plasma t1\u002F2 of AHB-171",[29,32,34,36,39,42,44,46,48,51,53,55,57,59,61,63,65,67],{"measure":30,"description":11,"timeFrame":31},"Part A & Part B:Fraction excreted in urine in percentage for AHB-171","Up to Day 3 in Part A; Up to Day 30 in Part B",{"measure":33,"description":11,"timeFrame":31},"Part A & Part B:Amount excreted in urine for AHB-171",{"measure":35,"description":11,"timeFrame":31},"Part A & Part B:Renal clearance for AHB-171",{"measure":37,"description":11,"timeFrame":38},"Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer","Up to 16 weeks in Part A; Up to 48 weeks in Part B",{"measure":40,"description":11,"timeFrame":41},"Part B:Plasma Cmax of AHB-171","Up to Day 31",{"measure":43,"description":11,"timeFrame":41},"Part B:Plasma Tmax of AHB-171",{"measure":45,"description":11,"timeFrame":41},"Part B Plasma AUC of AHB-171",{"measure":47,"description":11,"timeFrame":41},"Part B Plasma t1\u002F2 of AHB-171",{"measure":49,"description":11,"timeFrame":50},"Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance","Up to 48 weeks",{"measure":52,"description":11,"timeFrame":50},"Part B: HBsAg Decline in CHB Participants at each assessment time point",{"measure":54,"description":11,"timeFrame":50},"Part B:Proportion of participants with HBsAg \u003C 1 IU\u002FmL, \u003C 10 IU\u002FmL, and \u003C 100 IU\u002FmL at each assessment time point.",{"measure":56,"description":11,"timeFrame":50},"Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU\u002FL) after HBsAg loss.",{"measure":58,"description":11,"timeFrame":50},"Part B Proportion of participants with HBV DNA \u003C LLOQ (10 IU\u002FmL)",{"measure":60,"description":11,"timeFrame":50},"Part B Proportion of participants with HBsAg \u003C LOD and HBV DNA \u003C LLOQ at each assessment time point",{"measure":62,"description":11,"timeFrame":50},"Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg",{"measure":64,"description":11,"timeFrame":50},"Part B The level of ALT.",{"measure":66,"description":11,"timeFrame":50},"PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN.",{"measure":68,"description":11,"timeFrame":50},"Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171",{"allocation":70,"interventionModel":71,"interventionModelDescription":11,"primaryPurpose":72,"observationalModel":11,"timePerspective":11,"maskingInfo":73},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":74,"maskingDescription":11,"whoMasked":75},"QUADRUPLE",[76,77,78,79],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[81,89],{"label":82,"type":83,"description":84,"interventionNames":85},"AHB-171 and placebo in CHB (Part B: MAD)","EXPERIMENTAL","Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment",[86,87,88],"Drug: AHB-171 Injection","Drug: Placebo","Drug: Nucleos(t)ide Analogue (NA)",{"label":90,"type":83,"description":91,"interventionNames":92},"AHB-171 and placebo in HP(Part A: SAD)","Drug: AHB-171Injection Drug: Placebo",[86,87],[94,99,103],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":11},"DRUG","AHB-171 Injection","AHB-171 Injection is adminstrated via subcutaneous injection",[82,90],{"type":95,"name":100,"description":101,"armGroupLabels":102,"otherNames":11},"Placebo","Placebo is admistrated via subcutaneous injection",[82,90],{"type":95,"name":104,"description":105,"armGroupLabels":106,"otherNames":11},"Nucleos(t)ide Analogue (NA)","Oral administration",[82],[108],{"name":109,"role":110,"phone":111,"phoneExt":11,"email":112},"Bella Lu","CONTACT","0571-86959519","clinicaltrial@ausperbio.com",[114],{"facility":115,"status":116,"city":117,"state":118,"zip":11,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"AusperBio Investigational Site","RECRUITING","Ch’ang-ch’un","Jilin","China","CN",{"type":122,"coordinates":123},"Point",[124,125],126.24667,42.74694,{"lat":125,"lon":124},[128,129,132],{"name":109,"role":110,"phone":111,"phoneExt":11,"email":112},{"name":130,"role":131,"phone":11,"phoneExt":11,"email":11},"Yanhua Ding","PRINCIPAL_INVESTIGATOR",{"name":133,"role":131,"phone":11,"phoneExt":11,"email":11},"Junqi Niu",{"type":135,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632248",false,"NCT07511218","A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB - 171 Injection in Healthy Participants (HP) and Chronic Hepatitis B(CHB) Participants","Inclusion Criteria:\n\n* Healthy Participants:\n* Male or female participants, aged 18-55 years old (inclusive);\n* Body mass index between 18.0 and 28.0 kg\u002Fm\\^2 (inclusive);\n* Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance;\n* Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug.\n* Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening.\n* CHB Participants:\n* Male or female participants, aged 18-65 years old (inclusive);\n* Body mass index between 18.0 and 32.0 kg\u002Fm\\^2 (inclusive);\n* Participants who take effective contraceptive measures as required;\n* HBsAg \\> 100 IU\u002FmL and ≤ 3000 IU\u002FmL, and HBV DNA \\\u003C 100 IU\u002FmL at screening.\n* Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening.\n\nExclusion Criteria:\n\n* Healthy Participants:\n* Currently participating in another study, or within 5 half-lives\u002F3 months of the last dose of a previous investigational product.\n* Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.\n* Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.\n* Allergy to any investigational drug component.\n* Heavy Smoking (\\> 5 cigarettes\u002Fday); history of drug\u002Falcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.\n* Blood donation\u002Floss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.\n* Abdominal skin issues that may affect drug injection\u002Fobservation.\n* Positive for HBV, HCV, HIV, or syphilis.\n* Clinically significant ECG abnormality or TdP risk factors.\n* Any condition judged unsuitable by investigator.\n* CHB Participants:\n* Currently participating in another study, or within 5 half-lives\u002F3 months of the last dose of a previous investigational product.\n* Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices.\n* History or suspicion of hepatocellular carcinoma (HCC); AFP \\> 50 ng\u002FmL.\n* Diagnosed or Suspected cirrhosis within 12 months.\n* History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV).\n* Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months.\n* Major injury\u002Fsurgery within 6 months, planned surgery during study, or acute infection within 14 days.\n* Allergy to any investigational drug component.\n* Blood donation\u002Floss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.\n* Abdominal skin issues that may affect drug injection\u002Fobservation.\n* Key laboratory result not suitable for clinical trial.\n* HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E.\n* Clinically significant ECG abnormality or TdP risk factors.\n* Any condition judged unsuitable by investigator.",true,"ALL","18 Years","65 Years",{"count":147,"type":148},110,"ESTIMATED","INTERVENTIONAL",[151],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.",[154],"Chronic Hepatitis B Infection",[156],"Hepatitis B, Chronic","2026-05-27",{"date":159,"type":160},"2026-06-01","ACTUAL",{"date":162,"type":160},"2026-04-13",{"date":164,"type":148},"2028-06-30",{"name":5,"class":6},1]