[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640828":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":38,"locations":44,"responsibleParty":67,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"AusperBio Therapeutics Inc.","INDUSTRY",[8,16,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])","EXPERIMENTAL",null,[13,14,15],"Drug: AHB-171","Drug: Placebo matching [Investigational Product]","Drug: Nucleos(t)ide Analogue (NA)",{"label":17,"type":10,"description":11,"interventionNames":18},"AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])",[13,14,15],{"label":20,"type":10,"description":11,"interventionNames":21},"AHB-171 and placebo in CHB (Part C: finite MD)",[13,14],{"label":23,"type":10,"description":11,"interventionNames":24},"AHB-171 and placebo in CHB (Part D: finite MD)",[13,14],[26,31,34],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","AHB-171","Injection",[20,23,9,17],{"type":27,"name":32,"description":29,"armGroupLabels":33,"otherNames":11},"Placebo matching [Investigational Product]",[20,23,9,17],{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Nucleos(t)ide Analogue (NA)","Oral administration",[9,17],[39],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Debbie Liao","CONTACT","(650) 650-2877","ausperbioclinicaltrials@ausperbio.com",[45,55],{"facility":46,"status":11,"city":47,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":11},"Queen Mary Hospital","Hong Kong","HK",{"type":50,"coordinates":51},"Point",[52,53],114.17469,22.27832,{"lat":53,"lon":52},{"facility":56,"status":11,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":11},"New Zealand Clinical Research","Grafton","Auckland","1010","New Zealand","NZ",{"type":50,"coordinates":63},[64,65],174.76566,-36.86029,{"lat":65,"lon":64},{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640828","phase-1-study-of-ahb-171-in-chronic-hepatitis-b-participants-100640828",false,"NCT07617194","Study of AHB-171 in Chronic Hepatitis B Participants","A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171","EXTEND-101","Inclusion Criteria:\n\n* Male or female participants, aged 18-65 years old (inclusive)\n* Body Mass Index between 19 to 35 kg\u002Fm2 (inclusive)\n* Body weight \\> or = 45 kg.\n* Documented HBV infection for ≥6 months prior to randomization.\n* For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.\n* For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.\n* Screening electrocardiogram (ECG) without clinically significant abnormalities\n* Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine\u002Fserum pregnancy test before dosing (unless permanently sterile or \\>2 years postmenopausal).\n* Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.\n* Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.\n\nExclusion Criteria:\n\n* Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).\n* Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).\n* History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).\n* Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng\u002FmL.\n* HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).\n* Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.\n* Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).\n* Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).\n* History or signs of vasculitis or related autoimmune diseases.\n* Malignancy within 5 years (except non-melanoma skin cancer).\n* Allergy to study drug components.\n* Recent major surgery\u002Ftrauma (within 3 months) or planned surgery during study.\n* Alcohol or substance abuse affecting compliance.\n* Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.\n* Participation in another clinical trial or recent investigational product use.\n* Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.\n* Recent or ongoing use of immunosuppressive\u002Fbiologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.\n* Need for long-term anticoagulants\u002Fantiplatelet drugs (unless safely stopped).\n* Any other condition making the participant unsuitable (per investigator).","ALL","18 Years","65 Years",{"count":81,"type":82},144,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts\u002Fcohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.",[88],"Hepatitis B, Chronic","NOT_YET_RECRUITING","2026-05-24",{"date":92,"type":93},"2026-06-01","ACTUAL",{"date":95,"type":82},"2026-07-06",{"date":97,"type":82},"2028-08-14",{"name":5,"class":6},2]