Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region

NCT07370207 | Recruiting Phase 2 DMC

• 1 other identifier: AB-10-8011
• Study Type: interventional
• Target: 84
• Locations: 6 countries
• Sites: 8

Brief Summary

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis; Chronic Hepatitis; Chronic Hepatitis B; Hepatitis B; Hepatitis B, Chronic; Hepatitis B Virus; hepatitis B virus e-antigen; AHB-137; Nucleos(t)ide analog; Nucleos(t)ide analogue; Antisense Oligonucleotide; Blood-Borne Infections; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with sustained response post AHB-137 treatment

  Sustained response defined as hepatitis B surface antigen (HBsAg) level below the limit of detection (LOD, 0.05 international units \[IU\]/mL) and HBV deoxyribonucleic acid (DNA) below the lower limit of quantification (LLOQ)

  24 Weeks post AHB-137 treatment

Secondary Outcomes (26)

• Proportion of participants with functional cure (FC) or sustained HBV DNA response off all HBV treatment

  Off-treatment follow-up (Week 48 to 96)

• Proportion of participants with functional cure (FC)

  Week 72

• Proportion of participants with sustained HBV DNA response

  From baseline through Week 72

• Proportion of participants with HBsAg ≤10 IU/mL and HBV DNA < Lower Limit of Quantification (LLOQ) post AHB-137 treatment

  24 weeks post AHB-137 treatment

• Proportion of participants with HBsAg <100 IU/mL and HBV DNA < LLOQ

  24 weeks post AHB-137 treatment and at Week 72

Study Arms (2)

Arm A: AHB-137 + 2 LDs

EXPERIMENTAL

AHB-137 300 mg subcutaneous (SC) weekly for 24 weeks with 2 loading doses (LDs) on Days 4 and 11

Drug: AHB-137

Arm B: AHB-137 + 3 LDs

EXPERIMENTAL

AHB-137 300 mg SC weekly for 24 weeks with 3 LDs on Days 4, 11, and 18

Drug: AHB-137

Interventions

AHB-137 DRUG

Subcutaneous injection

Arm A: AHB-137 + 2 LDs; Arm B: AHB-137 + 3 LDs

Eligibility Criteria

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

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.
• Body mass index (BMI) ≤35 kg/m².
• Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
• Hepatitis B e antigen (HBeAg) negative at Screening.
• Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
• HBV DNA below the lower limit of quantification (LLOQ) at Screening.
• Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening.
• Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening.
• Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
• Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.
• Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.

You may not qualify if:

• Participants will be excluded from the study if any of the following criteria apply:
• Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant
• Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage).
• Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy.
• History of immune thrombocytopenia.
• Current suspected liver cirrhosis and/or evidence of cirrhosis defined as liver stiffness measurement (LSM) \>9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography).
• History of liver cirrhosis defined by liver biopsy or by LSM \>12 kPa by FibroScan® or equivalent imaging modality.
• Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
• History of extrahepatic diseases potentially associated with HBV infection, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension.
• Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.
• Abnormal laboratory values at Screening meeting any of the following criteria:
• Serum albumin \<3.5 g/dL
• Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² calculated using the CKD-EPI equation (or JSN-CKDI equation for participants in Japan)
• International normalized ratio (INR) \>1.25
• Platelet count \<125 × 10⁹/L

Sponsors & Collaborators

• AusperBio Therapeutics Inc.: lead

Study Sites (8)

St Vincents Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

Queen Mary Hospital - PPDS

Hong Kong, China

NOT YET RECRUITING

New Zealand Clinical Research

Grafton, Auckland, 1010, New Zealand

RECRUITING

National University Hospital - Singapore

Singapore, 119074, Singapore

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Chiayi Christian Hospital

Chiayi City, 60002, Taiwan

NOT YET RECRUITING

E-DA Hospital

Kaohsiung City, 82445, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hepadnaviridae Infections

Study Officials

• Audrey Lau, MD, PhD

  AusperBio Therapeutics Inc.

  STUDY CHAIR

Central Study Contacts

Debbie Liao

CONTACT

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

Toll Free-North America

CONTACT

(866) 928-7737

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); CN (1); NZ (1); KR (1); TW (3); AU (1)