Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions

NCT07654283 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AB-10-80122025-524159-30-00
• Study Type: interventional
• Target: 70
• Locations: 6 countries
• Sites: 9

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 CHB treated with Nucleos(t)ide Analogue (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 analogue; Nucleos(t)ide analog; 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 persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)

  24 Weeks post AHB-137 treatment (Week 48)

Secondary Outcomes (30)

• Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ

  Off-treatment follow-up (Week 48 to 72)

• Proportion of participants with HBsAg < LOD

  Week 72

• Proportion of participants with HBV DNA < LLOQ

  From baseline through Week 72

• Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment

  24 weeks post AHB-137 treatment

• Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA at weeks 48 and 72

  24 weeks post AHB-137 treatment and at Week 72

Study Arms (2)

Arm A: Dose Regimen A

EXPERIMENTAL

Participants receive AHB-137 according to dosing regimen A.

Drug: AHB-137

Arm B: Dose Regimen B

EXPERIMENTAL

Participants receive AHB-137 according to dosing regimen B.

Drug: AHB-137

Interventions

AHB-137 DRUG

Subcutaneous injection

Arm A: Dose Regimen A; Arm B: Dose Regimen B

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 and up to 65 years of age (inclusive) 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.
• Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
• HBV DNA meeting protocol-specified virologic criteria at Screening.
• Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.
• Alanine aminotransferase (ALT) meeting protocol-specified criteria 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.
• Males 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.
• Concomitant clinically significant liver disease.
• Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
• History of immune thrombocytopenia.
• Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable.
• History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
• 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.
• 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.
• Protocol-specified abnormal laboratory values at Screening.
• History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.
• History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.
• History of hypersensitivity or allergy to any component of the investigational product (IP).
• Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.

Sponsors & Collaborators

• AusperBio Therapeutics Inc.: lead

Study Sites (9)

Stanford University

Palo Alto, California, 94304-1509, United States

Location

University of Maryland

Baltimore, Maryland, 21201-1009, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215-2100, United States

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Clinica Mangiagalli

Milan, 20122, Italy

Location

Vall d'Hebron Hospital

Barcelona, 8035, Spain

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

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 DIRECTOR

Central Study Contacts

Maggie Davis

CONTACT

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

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: May 28, 2026
• First Posted: June 17, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): July 26, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IT (1); ES (1); GB (1); CA (1); FR (1)