[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose-escalation phase I clinical trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2072 tablets in healthy Chinese participants.
主要目的:评价SYH2072片在中国健康参与者中单次和多次口服给药后的安全性和耐受性;
次要目的:评价SYH2072片在中国健康参与者中单次和多次口服给药后的药代动力学(PK)、药效学(PD)特征;评价SYH2072片在中国健康参与者中单次口服给药对QT/QTc间期的影响;评价食物对SYH2072片单次口服给药后PK特征的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of SYH2072 tablets after single and multiple oral administration in healthy Chinese participants;
Secondary objectives: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of SYH2072 tablets after single and multiple oral administration in healthy Chinese participants; to evaluate the effect of a single oral administration of SYH2072 tablets on the QT/QTc interval in healthy Chinese participants; and to evaluate the effect of food on the PK characteristics of SYH2072 tablets after a single oral administration.