一项评估RS-C1001片剂在中国健康受试者中安全性、耐受性、药代动力学特征、药效动力学和食物影响的随机、双盲、安慰剂对照、单次和多次口服给药剂量递增的研究
1、主要目的:评估RS-C1001片剂在中国健康受试者中单剂量和多剂量口服给药后的安全性和耐受性
2、次要目的:(1)评估RS-C1001片剂在中国健康受试者中单剂量和多剂量口服给药后的药代动力学(PK)特征
(2)评估食物对RS-C1001片剂在中国健康受试者中PK的影响
(3)评估 RS-C1001片剂在中国健康受试者中多剂量口服给药后的药效动力学(PD)特征
(4)尿液和血浆中RS-C1001代谢物鉴定
3、探索性目的:(1)初步评估RS-C1001片剂在中国健康受试者单次和多次口服给药后的血药浓度与QTc间期的关系
(2)初步探索RS-C1001片剂在中国健康受试者多次口服给药后对生物标志物FGF21的影响
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of RS-C1001 Tablets in Chinese Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects.
This study will consist of two parts (Parts A and B). 42 subjects have been planned for Part A and 30 subjects for Part B.
100 项与 RS-C1001 相关的专利(医药)