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

NCT ID: NCT06829329

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2025-11-30

Brief 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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AHB-137 and placebo

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be administered .

Placebo

Intervention Type: DRUG

Placebo will be administered .

AHB-137 and Nucleos(t)Ide Analogue (NAs)

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be administered .

NAs

Intervention Type: DRUG

NAs will be administered.

Interventions

AHB-137

AHB-137 will be administered .

Intervention Type: DRUG

NAs

NAs will be administered.

Intervention Type: DRUG

Placebo

Placebo will be administered .

Intervention Type: DRUG

Eligibility Criteria

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;
• History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
• Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
• Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
• Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ausper Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

AB-10-8008

Identifier Type: -

Identifier Source: org_study_id