This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued. — At the 24th week after all treatment for CHB was discontinued
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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