Study of AHB-171 in Chronic Hepatitis B Participants

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Hepatitis B, Chronic

In brief

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/cohorts 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.

Key facts

Study ID

NCT07617194

Run by

AusperBio Therapeutics Inc.

People needed

144

Starts

2026-07-06

Expected to finish

2028-08-14

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants, aged 18-65 years old (inclusive)
• Body Mass Index between 19 to 35 kg/m2 (inclusive)
• Body weight > or = 45 kg.
• Documented HBV infection for ≥6 months prior to randomization.
• For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
• For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
• Screening electrocardiogram (ECG) without clinically significant abnormalities
• Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
• Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
• Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.

You may not qualify if…

• Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
• Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
• History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
• Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
• HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
• Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
• Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
• Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
• History or signs of vasculitis or related autoimmune diseases.
• Malignancy within 5 years (except non-melanoma skin cancer).
• Allergy to study drug components.
• Recent major surgery/trauma (within 3 months) or planned surgery during study.
• Alcohol or substance abuse affecting compliance.
• Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
• Participation in another clinical trial or recent investigational product use.
• Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
• Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
• Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
• Any other condition making the participant unsuitable (per investigator).

Where it is running

• Queen Mary Hospital — Hong Kong, Hong Kong
• New Zealand Clinical Research — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.