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Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB) | Clinical Trials | Clareo Health

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Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB

NCT06829329•Ausper Biopharma Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
•Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
•Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive);
•Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
•At screening, ALT\<3×upper limit of normal (ULN);
•Use effective contraception as required;
•HBV DNA within the specified range at screening;
•HBsAg was within the specified range at screening.

Exclusion Criteria

•Clinically significant abnormalities except chronic HBV infection;
•Any clinically significant liver diseases;
•Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
•Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
•Hepatobiliary neoplasm malignant;
•The laboratory examination results are obviously abnormal;
•History of vasculitis or signs and symptoms of potential vasculitis;
•Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
•History of extrahepatic disease that may be related to HBV immune status;
•Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
+7 more criteria

Locations (4)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 13, 2024

Primary Completion Date

October 21, 2025

Completion Date

November 1, 2025

Last Updated

September 24, 2025

Enrollment

105

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

AHB-137

DRUG

NAs

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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