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

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

Recruiting
18-65 years
All
Phase 2

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Overview

This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.

Eligibility

Inclusion Criteria:

  • Voluntarily participate in the study and sign the informed consent form;
  • 18-65 years of age (including boundary values) ;
  • Body mass index met the requirements;
  • Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
  • Meet the relevant requirements for prior medications;
  • HBsAg and HBV DNA and liver function indicators meet the requirements;
  • Effective contraception as required;

Exclusion Criteria:

  • Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
  • Associated liver disease;
  • Any serious infection other than CHB infection requires intravenous anti-infective therapy;
  • HCV RNA positive, HIV antibody positive, syphilis positive;
  • Abnormal laboratory results;
  • Diseases associated with vascular inflammatory conditions;
  • QT interval corrected heart rate (Fridericia method) abnormal;
  • History of malignancy or ongoing assessment of possible malignancy;
  • History of allergies, or allergic constitution;
  • Participants with recent major trauma or major surgery, or planning surgery;
  • Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
  • Prior/current use of prohibited medications;
  • Inappropriate for participation in this trial as judged by the investigator.

Study details
    Chronic Hepatitis B

NCT07137910

Ausper Biopharma Co., Ltd.

13 May 2026

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