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

NCT06829329 | Active Not Recruiting Phase 2

• 1 other identifier: AB-10-8008
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 6

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

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).

  Up to 24 weeks

Secondary Outcomes (15)

• Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.

  Up to 48 weeks

• Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.

  Up to 48 weeks

• Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.

  Up to 48 weeks

• Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb

  Up to 48 weeks

• Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb

  Up to 48weeks

Study Arms (2)

AHB-137 and placebo

EXPERIMENTAL

Drug: AHB-137; Drug: Placebo

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

EXPERIMENTAL

Drug: AHB-137; Drug: NAs

Interventions

AHB-137 DRUG

AHB-137 will be administered .

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

NAs DRUG

NAs will be administered.

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

Placebo DRUG

Placebo will be administered .

AHB-137 and placebo

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 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (6)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 401336, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

AusperBio Investigational Site

Guangzhou, Guangdong, China

Location

AusperBio Investigational Site

Changzhou, Jiangsu, China

Location

The Third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

nas

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 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: February 11, 2025
• First Posted: February 17, 2025
• Study Start: December 13, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)