A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Recruiting now · Phase 2
Conditions studied: Chronic Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT07137910
- Run by
- Ausper Biopharma Co., Ltd.
- People needed
- 200
- Starts
- 2025-09-04
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- AusperBio Investigational Site — Jilin City, Changchun, China (enrolling)
- AusperBio Investigational Site — Xiamen, Fujian, China (enrolling)
- AusperBio Investigational Site — Nanning, Guangxi, China (enrolling)
- AusperBio Investigational Site — Beijing, Beijing Municipality, China (enrolling)
- AusperBio Investigational Site — Shenzhen, Guangdong, China
- AusperBio Investigational Site — Zhengzhou, Henan, China
- AusperBio Investigational Site — Changzhou, Jiangsu, China
- AusperBio Investigational Site — Chengdu, Sichuan, China
- AusperBio Investigational Site — Hangzhou, Zhejiang, China
- AusperBio Investigational Site — Chongqing, Chongqing Municipality, China
- AusperBio Investigational Site — Chongqing, Chongqing Municipality, China
- AusperBio Investigational Site — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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