A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Recruiting · NCT07137910 · Interventional (participants receive a specific treatment) · Lead sponsor: Ausper Biopharma Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
AHB-137NA therapy
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
12 locations listed.
- AusperBio Investigational Site - Beijing, Beijing Municipality, China
- AusperBio Investigational Site - Jilin City, Changchun, China
- AusperBio Investigational Site - Chongqing, Chongqing Municipality, China
- AusperBio Investigational Site - Chongqing, Chongqing Municipality, China
- AusperBio Investigational Site - Xiamen, Fujian, China
- AusperBio Investigational Site - Guangzhou, Guangdong, China
- AusperBio Investigational Site - Shenzhen, Guangdong, China
- AusperBio Investigational Site - Nanning, Guangxi, 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