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Clinical Trials in China / NCT07635186
Recruiting Phase 2

A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

NCT07635186 · tracked via the Priya Life Science China tracker
Sponsor
Ausper Biopharma Co., Ltd.
Phase
Phase 2
Started
2026-06-05
Last updated
2026-07-29

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

AHB-137 →Placebo

AHB-137: AHB-137 will be administered subcutaneously.

Placebo: Placebo will be administered subcutaneously.

Study summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol. * Aged 18-65 years (including boundary values). * Body mass index between the range of 18-32 kg/m2 (inclusive boundary values). * HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue. * HBsAg and HBV DNA values met protocol requirements at screening. * ALT \< 3xULN at screening. * Use highly effective contraception as required. Exclusion Criteria: * Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection. * Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status. * Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization. * Hepatitis C virus (HCV) infection or \< 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive). * Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \> 9.0 kPa at screening. * Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy. * Laboratory test results do not meet the criteria. * Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis. * Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening. * Allergic to AHB-137 ingredients, or history of drug allergy or other allergies. * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial. * Participants are participating in another clinical trial or failing to wash out as required. * Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial. * Participants that require regular long-term anticoagulants. * Abnormal thyroid function. * Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B. * Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
AusperBio Investigational Site Beijing Beijing Municipality Recruiting
AusperBio Investigational Site Chongqing Chongqing Municipality Recruiting
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
AusperBio Investigational Site Xiamen Fujian Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Jiangmen Guangdong Recruiting
AusperBio Investigational Site Meizhou Guangdong Recruiting
AusperBio Investigational Site Qingyuan Guangdong Recruiting
AusperBio Investigational Site Shenzhen Guangdong Recruiting
AusperBio Investigational Site Shenzhen Guangdong Recruiting
AusperBio Investigational Site Liuzhou Guangxi Recruiting
AusperBio Investigational Site Wuhan Hubei Recruiting
AusperBio Investigational Site Wuhan Hubei Recruiting
AusperBio Investigational Site Yichang Hubei Recruiting
AusperBio Investigational Site Changsha Hunan Recruiting
AusperBio Investigational Site Changsha Hunan Recruiting
AusperBio Investigational Site Changsha Hunan Recruiting
AusperBio Investigational Site Nanjing Jiangsu Recruiting
AusperBio Investigational Site Nanchang Jiangxi Recruiting
AusperBio Investigational Site Changchun Jilin Recruiting
AusperBio Investigational Site Shenyang Liaoning Recruiting
AusperBio Investigational Site Shanghai Shanghai Municipality Recruiting
AusperBio Investigational Site Shanghai Shanghai Municipality Recruiting
AusperBio Investigational Site Shanghai Shanghai Municipality Recruiting
AusperBio Investigational Site Xi’an Shanxi Recruiting
AusperBio Investigational Site Xi’an Shanxi Recruiting
AusperBio Investigational Site Chengdu Sichuan Recruiting
AusperBio Investigational Site Chengdu Sichuan Recruiting
AusperBio Investigational Site Chengdu Sichuan Recruiting
AusperBio Investigational Site Kunming Yunan Recruiting
AusperBio Investigational Site Hangzhou Zhejiang Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Ausper Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

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.

View NCT07635186 on ClinicalTrials.gov ↗ ← All trials in China