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

Ausper Biopharma

Status and phase

Not yet enrolling

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: AHB-137

Study type

Interventional

Funder types

Industry

Identifiers

NCT07137910

AB-10-8009

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.