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

NCT ID: NCT06550128

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2026-06-30

Brief Summary

AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.

Detailed Description

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

Conditions

Hepatitis B, Chronic

Study Design

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

Study Groups

AHB-137

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 injection will be administered subcutaneously.

Placebo

Group Type: PLACEBO_COMPARATOR

AHB-137 and Placebo

Intervention Type: DRUG

AHB-137and placebo will be administered subcutaneously.

AHB-137 (16 weeks)

Group Type: EXPERIMENTAL

AHB-137 (16weeks)

Intervention Type: DRUG

AHB-137 injection will be administered subcutaneously.

Interventions

AHB-137

AHB-137 injection will be administered subcutaneously.

Intervention Type: DRUG

AHB-137 and Placebo

AHB-137and placebo will be administered subcutaneously.

Intervention Type: DRUG

AHB-137 (16weeks)

AHB-137 injection will be administered subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study and discontinue their NA therapy according to the protocol;

2. At least 18 years old at the time of signing of the informed consent;

3. Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive) ;

4. Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;

5. Participants whose serum HBsAg positive for at least 6 months prior to screening;

6. Participants who have stable on NA therapy at least 6 months prior to screening;

7. Participants with HBsAg concentration >100 IU/mL and≤3000 IU/mL, HBV DNA<100 IU/mL;

8. Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);

9. For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.

Exclusion Criteria

1. Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;

2. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;

3. Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;

4. Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;

5. Liver stiffness measurement (LSM) > 9.0 kPa when screening;

6. Diagnosed or suspected hepatocellular carcinoma;

7. The laboratory examination results are obviously abnormal;

8. History of vasculitis or signs and symptoms of potential vasculitis;

9. History of extrahepatic disease that may be related to HBV immune status;

10. 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.

11. Administration of any Interferon within 6 months prior to screening;

12. History of malignant tumor within the past 5 years;

13. 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;

14. Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;

15. 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;

16. Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days;

17. Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;

18. 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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ausper Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junqi Niu

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Jinlin Hou

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

The third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Nanfang Hospital, Southern Medical University

Guangzhou, , China

The First Hospital of Jilin University

Jilin, , China

Countries

China

Other Identifiers

AB-10-8003

Identifier Type: -

Identifier Source: org_study_id