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

Last updated: September 22, 2025
Sponsor: Ausper Biopharma Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

NAs

AHB-137

Placebo

Clinical Study ID

NCT06829329
AB-10-8008
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participants voluntarily participate in the study, and sign the Informed ConsentForm (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) atthe time of signing the ICF;

  • Male participants weighed higher than 50 kg and female participants weighted higherthan 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 monthsprior 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

Exclusion Criteria:

  • Clinically significant abnormalities except chronic HBV infection;

  • Any clinically significant liver diseases;

  • Participants with severe infection requiring systemic anti-infection treatment 1month 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 forshort-term use (≤2 weeks) or topical/inhaled steroids. Administration ofimmunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the firststudy intervention or have a history of vaccination within 1 month prior toscreening or planned administration during the study;

  • History of malignancy within the past 5 years or the discovery of suspected tumorsduring the screening period;

  • Any suspicion of drug component allergy, or allergic constitution (various drug andfood allergy, and judged by the investigator to be clinically significant) inparticipants;

  • Participants who have significant trauma or major surgery within 3 months beforescreening, 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 monthbefore screening;

  • Those who are participating in another clinical trial, or have not undergone aprotocol-specified washout period prior to this study;

  • Participants who have received any oligonucleotide or small molecule interferingribonucleic acid (siRNA) drugs;

  • Any other circumstances or conditions for which the investigator considers that theparticipants are inappropriate to participate in the study.

Study Design

Total Participants: 105
Treatment Group(s): 3
Primary Treatment: NAs
Phase: 2
Study Start date:
December 13, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 401336
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 401336
    China

    Site Not Available

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Site Not Available

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou 1810821, Fujian 1811017
    China

    Site Not Available

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • The Third People's Hospital of Zhenjiang

    Zhenjiang 1784642, Jiangsu 1806260
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310052
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310052
    China

    Site Not Available

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