Studies a new drug, AHB-171, in people with chronic hepatitis B
Tests the safety of AHB-171 in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Study of AHB-171 in Chronic Hepatitis B Participants
Key facts
- Where
- Grafton, New ZealandSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07617194, who can take part
Where in New Zealand
- New Zealand Clinical ResearchGrafton, New ZealandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AusperBio Therapeutics Inc.
- Trial code
- NCT07617194
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
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.
Inclusion: 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.
Exclusion: 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); Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment; Recent major surgery/trauma (within 3 months) or planned surgery during study; 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); 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); Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative); History or signs of vasculitis or related autoimmune diseases; Malignancy within 5 years (except non-melanoma skin cancer); Allergy to study drug components; Any other condition making the participant unsuitable (per investigator); Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria); Alcohol or substance abuse affecting compliance; Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.