RecruitingPhase 2NCT07137910

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

An Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B Previously Treated With Nucleos (t) Ide Analogues (NA)

Sponsor

Ausper Biopharma Co., Ltd.

Enrollment

60 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Voluntarily participate in the study and sign the informed consent form;
-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 Criteria13

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.