Study of AHB-171 in Chronic Hepatitis B Participants

NCT07617194 | Not Yet Recruiting Phase 1

• 1 other identifier: AB-17-8001
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (7)

• Incidence of Adverse Events (AEs) [Safety and Tolerability]

  Up to 72 weeks

• The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.

  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

  Up to 72 weeks

• Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]

  Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure

  Up to 72 weeks

• Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]

  12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.

  Up to 72 weeks

• Incidence of laboratory abnormalities [Safety and Tolerability]

  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

  Up to 72 weeks

Secondary Outcomes (27)

• Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study

  Up to 72 weeks

• Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.

  Up to 72 weeks

• Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.

  Up to 72 weeks

• Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.

  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.

  Up to 72 weeks

Study Arms (4)

AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])

EXPERIMENTAL

Drug: AHB-171; Drug: Placebo matching [Investigational Product]; Drug: Nucleos(t)ide Analogue (NA)

AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])

EXPERIMENTAL

Drug: AHB-171; Drug: Placebo matching [Investigational Product]; Drug: Nucleos(t)ide Analogue (NA)

AHB-171 and placebo in CHB (Part C: finite MD)

EXPERIMENTAL

Drug: AHB-171; Drug: Placebo matching [Investigational Product]

AHB-171 and placebo in CHB (Part D: finite MD)

EXPERIMENTAL

Drug: AHB-171; Drug: Placebo matching [Investigational Product]

Interventions

AHB-171 DRUG

Injection

AHB-171 and placebo in CHB (Part C: finite MD); AHB-171 and placebo in CHB (Part D: finite MD); AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]); AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])

Placebo matching [Investigational Product] DRUG

Injection

AHB-171 and placebo in CHB (Part C: finite MD); AHB-171 and placebo in CHB (Part D: finite MD); AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]); AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])

Nucleos(t)ide Analogue (NA) DRUG

Oral administration

AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]); AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AusperBio Therapeutics Inc.: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

New Zealand Clinical Research

Grafton, Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Debbie Liao

CONTACT

(650) 650-2877; ausperbioclinicaltrials@ausperbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 1, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): October 8, 2027
• Study Completion (Estimated): August 14, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); NZ (1)