[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral escalating doses of GS1-144 tablets and the effect of food on the pharmacokinetics of GS1-144 in the Chinese population
主要研究目的:评估GS1-144 片单次、多次口服给药剂量递增的安全性和耐受性;
次要研究目的:1)评估GS1-144片在健康受试者中单次、多次口服给药的药代动力学(PK)特征;2)评估高脂餐对PK的影响;3)评估健康受试者口服GS1-144片后QT/QTc间期变化水平。
探索性研究目的:1)初步评估GS1-144片在人体内代谢特征;
2)评估GS1-144片在绝经后健康女性体内的药效学(PD)特征。
[Translation] Main study objectives: To evaluate the safety and tolerability of GS1-144 tablets after single and multiple oral doses;
Secondary study objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of GS1-144 tablets after single and multiple oral administration in healthy subjects; 2) To evaluate the effect of high-fat meal on PK; 3) To evaluate the level of QT/QTc interval changes after oral administration of GS1-144 tablets in healthy subjects.
Exploratory study objectives: 1) To preliminarily evaluate the metabolic characteristics of GS1-144 tablets in humans;
2) To evaluate the pharmacodynamic (PD) characteristics of GS1-144 tablets in healthy postmenopausal women.