[Translation] A phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AHB-121 injection in healthy participants and participants with chronic hepatitis B.
主要目的:评估AHB-121注射液在健康参与者及CHB参与者中单次皮下注射的安全性和耐受性;
次要目的:评估AHB-121注射液在健康参与者中单次皮下注射的药代动力学(PK)特征,免疫原性,以及注射后QT/QTc间期变化及血
药浓度与QTc间期的关系;评估AHB-121注射液在CHB参与者中多次皮下注射的PK特征,药效动力学(PD),免疫原性,细胞因子的变化以及PK/PD关系。
[Translation] Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of AHB-121 in healthy and CHB participants;
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity, and post-injection QT/QTc interval changes and the relationship between plasma drug concentration and QTc interval of a single subcutaneous injection of AHB-121 in healthy participants; and to evaluate the PK characteristics, pharmacodynamics (PD), immunogenicity, cytokine changes, and PK/PD relationship of multiple subcutaneous injections of AHB-121 in CHB participants.