Status:
RECRUITING
A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Lead Sponsor:
Ausper Biopharma Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide ana...
Detailed Description
The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, ...
Eligibility Criteria
Inclusion
- Voluntarily participated in the study and signed an informed consent form;
- Aged between 18 and 55 years at the time of signing the informed consent form;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative or positive at screening;
- HBsAg or HBV DNA positive for at least 6 months;
- Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
- 100 IU/mL \< HBsAg ≤ 3000 IU/mL and HBV DNA \< 100 IU/mL at screening;
- Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- Effective contraception as required.
Exclusion
- Clinically significant abnormalities other than a history of CHB infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Liver stiffness value (LSM) \> 9.0 kPa at screening;
- Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
- Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
- Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
- History of extrahepatic disease possibly related to HBV immune status;
- Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy;
- Receiving or using any interferon-containing therapy within 12 months prior to screening;
- History of malignancy within 5 years prior to screening or being evaluated for possible malignancy;
- Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant);
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening;
- Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening;
- Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment;
- Obviously abnormal laboratory test results;
- History of vasculitis or signs and symptoms of underlying vasculitis;
- Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
Key Trial Info
Start Date :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06993480
Start Date
June 18 2025
End Date
December 1 2026
Last Update
December 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China