A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

Launched by AUSPER BIOPHARMA CO., LTD. · May 20, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment called AHB-137 injection for people with Chronic Hepatitis B (CHB) who do not have a specific virus marker known as HBeAg. The goal is to see how well this injection works in fighting the virus and how it helps the immune system respond to the infection. The study is in its second phase and will take place at one location.

To participate, individuals need to be between 18 and 50 years old, have been on antiviral therapy for CHB for more than six months, and meet certain health criteria, such as having specific levels of infection markers in their blood. Participants will be closely monitored for their health during the trial. It's important to note that some people may not be eligible if they have other serious health conditions or if they are currently taking certain medications. The trial is not yet recruiting, so interested individuals will need to wait for further announcements about when they can enroll.

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Eligibility criteria

• Inclusion Criteria:
• • Voluntarily participated in the study and signed an informed consent form;
• • Aged between 18 and 50 years at the time of signing the informed consent form;
• • Body mass index (BMI) within the range of 18-30 kg/ m2;
• • HBeAg negative 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 Criteria:
• • 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 small molecule interfering ribonucleic acid (siRNA) drug;
• • 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.