[Translation] A randomized, double-blind, placebo-controlled, single or multiple dose escalation and food effect (open) Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of CMS-D001 in healthy subjects
主要目的: 评价单次或多次口服CMS-D001的安全性和耐受性;次要目的:1) 评价单次或多次口服CMS-D001的药代动力学(PK)特征,2) 评价单次或多次口服CMS-D001的药效动力学(PD)特征;其他目的:1) 考察血浆中的代谢产物/特征,2) 评价口服CMS-D001对心脏QT间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of single or multiple oral doses of CMS-D001; Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of single or multiple oral doses of CMS-D001, 2) To evaluate the pharmacodynamic (PD) characteristics of single or multiple oral doses of CMS-D001; Other objectives: 1) To investigate the metabolites/characteristics in plasma, 2) To evaluate the effects of oral CMS-D001 on the cardiac QT interval.