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

NCT06550128 | Active Not Recruiting Phase 2

• 1 other identifier: AB-10-8003
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.

  Up to 24 weeks

Secondary Outcomes (15)

• Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed

  At 8 weeks

• Proportion of participants meeting NA treatment discontinuation criteria.

  Up to 48 weeks

• Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline

  Up to 72 weeks

• Percentage of participants with different levels of HBsAg reduction compared with baseline

  Up to 72 weeks

• Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.

  Up to 72 weeks

Study Arms (3)

AHB-137

EXPERIMENTAL

Drug: AHB-137

Placebo

PLACEBO COMPARATOR

Drug: AHB-137 and Placebo

AHB-137 (16 weeks)

EXPERIMENTAL

Drug: AHB-137 (16weeks)

Interventions

AHB-137 DRUG

AHB-137 injection will be administered subcutaneously.

AHB-137

AHB-137 and Placebo DRUG

AHB-137and placebo will be administered subcutaneously.

Placebo

AHB-137 (16weeks) DRUG

AHB-137 injection will be administered subcutaneously.

AHB-137 (16 weeks)

Eligibility Criteria

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

You may qualify if:

• 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;
• At least 18 years old at the time of signing of the informed consent;
• Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive) ;
• Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
• Participants whose serum HBsAg positive for at least 6 months prior to screening;
• Participants who have stable on NA therapy at least 6 months prior to screening;
• Participants with HBsAg concentration \>100 IU/mL and≤3000 IU/mL, HBV DNA\<100 IU/mL;
• Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
• 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.

You may not qualify if:

• 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;
• 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.;
• Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
• Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
• Liver stiffness measurement (LSM) \> 9.0 kPa when screening;
• Diagnosed or suspected hepatocellular carcinoma;
• The laboratory examination results are obviously abnormal;
• History of vasculitis or signs and symptoms of potential vasculitis;
• 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.
• Administration of any Interferon within 6 months prior to screening;
• History of malignant tumor within the past 5 years;
• 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;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (6)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

The First Hospital of Jilin University

Jilin, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Junqi Niu

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Jinlin Hou

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: July 10, 2024
• Primary Completion: February 2, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)