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

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

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.

Conditions2

Interventions1

Related trials

• A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs — Ausper Biopharma Co., Ltd.
• Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region — AusperBio Therapeutics Inc.

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