Study of AHB-171 in Chronic Hepatitis B Participants
- Summary
- 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.
- Acronym
- EXTEND-101
- Short title
- Study of AHB-171 in Chronic Hepatitis B Participants
- Official title
- A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2028-08-14
- First posted
- 2026-06-01
- Registry last updated
- 2026-06-01
- Primary completion date
- 2027-10-08
- Start date
- 2026-07-06
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AusperBio Therapeutics Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07617194
- ClinicalTrials.gov ID
- NCT07617194
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Participants
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Timeframe: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Timeframe: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Timeframe: Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Timeframe: Up to 72 weeks
Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
Timeframe: Up to 72 weeks
12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.
Incidence of laboratory abnormalities [Safety and Tolerability]
Timeframe: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171
Timeframe: Up to 72 weeks
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Timeframe: Up to 72 weeks
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Timeframe: Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) levels
Timeframe: Up to 72 weeks
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants experiencing virologic relapse.
Timeframe: Up to 72 weeks
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Time to participants experiencing virologic relapse.
Timeframe: Up to 72 weeks
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs.
Timeframe: Up to 72 weeks
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Timeframe: Up to 72 weeks
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Plasma PK parameters AUC of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Plasma PK parameter Cmax of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Timeframe: Up to 72 weeks
Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Timeframe: Up to 72 weeks
Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Timeframe: Up to 72 weeks
And 2 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- No
- 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.
- 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).
- Queen Mary HospitalHong Kong, Hong Kong
- New Zealand Clinical ResearchGrafton, New Zealand
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Chronic hepatitis B virus infection Primary condition