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

Ausper Biopharma

Status and phase

Active, not recruiting

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: NAs

Drug: AHB-137

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06829329

AB-10-8008

Details and patient eligibility

About

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.

Enrollment

105 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
At screening, ALT<3×upper limit of normal (ULN);
Use effective contraception as required;
HBV DNA within the specified range at screening;
HBsAg was within the specified range at screening.

Exclusion criteria

Clinically significant abnormalities except chronic HBV infection;
Any clinically significant liver diseases;
Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
Hepatobiliary neoplasm malignant;
The laboratory examination results are obviously abnormal;
History of vasculitis or signs and symptoms of potential vasculitis;
Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
History of extrahepatic disease that may be related to HBV immune status;
Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.