A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

Ki vehet részt

• Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol
• Aged between 18 and 65 years at the time of signing the ICF
• 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
• Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening
• Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN)
• Effective contraception as required

Ki nem vehet részt

• Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine
• Concomitant clinically significant other liver diseases
• Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening
• Previous/current manifestations of hepatic decompensation
• Serious mental illness or history of serious mental illness prior to screening
• Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study
• Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial
• Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs
• Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug
• Clinically significant abnormalities other than a history of chronic HBV infection
• HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive
• History of extrahepatic disease possibly related to HBV immune status
• Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy
• Suspected history of allergy to any component of the study drug, or allergic constitution
• Patients with uncontrolled epilepsy and other progressive neurological disorders
• Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study
• Obviously abnormal laboratory test results
• History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions
• QT interval corrected for heart rate (Fridericia method) abnormal
• Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa
• Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening
• Thyroid dysfunction