a study to evaluate the antiviral activity and immune response of ahb-137 injection in participants with chronic hepatitis b (chb)

Conditions: Chronic Hepatitis B

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 hbeag-negative chb treated with nucleos (t) ide analogues.

the study is to evaluate the antiviral activity and immune response of ahb-137 injection in participants with hbeag-negative chb treated with nucleos(t)ide analogues. the study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an ahb-137 treatment period (24 weeks) and a follow-up period (24 weeks).

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.

Keywords: hepatitis b, chronic