[Translation] A randomized, double-blind, placebo-controlled, single and multiple oral dose escalation study to evaluate the safety, tolerability, pharmacokinetic profile, pharmacodynamics, and food effects of RS-C1001 tablets in healthy Chinese subjects
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
[Translation] 1. Primary objective: To evaluate the safety and tolerability of RS-C1001 tablets after single and multiple oral doses in healthy Chinese subjects
2. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of RS-C1001 tablets after single and multiple oral doses in healthy Chinese subjects
(2) To evaluate the effect of food on the PK of RS-C1001 tablets in healthy Chinese subjects
(3) To evaluate the pharmacodynamic (PD) characteristics of RS-C1001 tablets after multiple oral doses in healthy Chinese subjects
(4) To identify RS-C1001 metabolites in urine and plasma
3. Exploratory objectives: (1) To preliminarily evaluate the relationship between the blood drug concentration and QTc interval of RS-C1001 tablets after single and multiple oral doses in healthy Chinese subjects
(2) To preliminarily explore the effect of RS-C1001 tablets on the biomarker FGF21 after multiple oral doses in healthy Chinese subjects