[Translation] A Phase I randomized, double-blind, placebo-controlled single and multiple dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, and food effects of CS060380 in healthy and LDL-C elevated subjects
主要目的:考察健康和 LDL-C 升高受试者单次和多次口服 CS060380 的安全性和耐受性
次要目的:考察健康和 LDL-C 升高受试者单次和多次口服 CS060380 的 PK特征,评价食物对健康受试者单次服用 CS060380 后 PK 特征的影响
探索性目的:探索LDL-C升高受试者多次口服 CS060380 的效动力学(PD)特征、甲状腺功能的影响、对QT间期的影响
[Translation] Primary purpose: To investigate the safety and tolerability of single and multiple oral administration of CS060380 in healthy and LDL-C elevated subjects
Secondary purpose: To investigate the PK characteristics of single and multiple oral administration of CS060380 in healthy and LDL-C elevated subjects, and to evaluate the effect of food on the PK characteristics of CS060380 after a single dose in healthy subjects
Exploratory purpose: To explore the PD characteristics, effect on thyroid function, and effect on QT interval of multiple oral administration of CS060380 in LDL-C elevated subjects