[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632248":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ausper Biopharma Co., Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"AHB-171 and placebo in CHB (Part B: MAD)","EXPERIMENTAL","Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment",[13,14,15],"Drug: AHB-171 Injection","Drug: Placebo","Drug: Nucleos(t)ide Analogue (NA)",{"label":17,"type":10,"description":18,"interventionNames":19},"AHB-171 and placebo in HP(Part A: SAD)","Drug: AHB-171Injection Drug: Placebo",[13,14],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AHB-171 Injection","AHB-171 Injection is adminstrated via subcutaneous injection",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo is admistrated via subcutaneous injection",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Nucleos(t)ide Analogue (NA)","Oral administration",[9],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Bella Lu","CONTACT","0571-86959519","clinicaltrial@ausperbio.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"AusperBio Investigational Site","RECRUITING","Ch’ang-ch’un","Jilin","China","CN",{"type":50,"coordinates":51},"Point",[52,53],126.24667,42.74694,{"lat":53,"lon":52},[56,57,60],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Yanhua Ding","PRINCIPAL_INVESTIGATOR",{"name":61,"role":59,"phone":26,"phoneExt":26,"email":26},"Junqi Niu",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100632248","phase-1-a-phase-i-clinical-study-of-ahb---171-in-healthy-participantshp-and-chronic-hepatitis-b-chb-participants-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":76,"type":77},110,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83],"Chronic Hepatitis B Infection",[85],"Hepatitis B, Chronic","2026-05-27",{"date":88,"type":89},"2026-06-01","ACTUAL",{"date":91,"type":89},"2026-04-13",{"date":93,"type":77},"2028-06-30",{"name":5,"class":6},1]