[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and food effects of single and multiple doses of YD6390 tablets in healthy subjects.
主要目的:评价YD6390片在健康受试者中单次和多次口服给药的安全性及耐受性。次要目的:评价YD6390片在健康受试者中单次和多次口服给药后的药代动力学(PK)特征。评价食物对健康受试者口服YD6390片的PK特征的影响。探索目的:评价YD6390片对健康受试者QT/QTc间期的影响。评价YD6390片在健康受试者中多次口服给药后的药效动力学(PD)特征。进行探索性物料平衡研究,考察尿液和粪便中YD6390原型药物的累积排泄率,并对血浆、尿液和粪便中的代谢产物进行鉴定分析。
[Translation] Primary objective: To evaluate the safety and tolerability of YD6390 tablets after single and multiple oral administration in healthy subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of YD6390 tablets after single and multiple oral administration in healthy subjects. To evaluate the effect of food on the PK characteristics of oral administration of YD6390 tablets in healthy subjects. Exploratory objective: To evaluate the effect of YD6390 tablets on the QT/QTc interval in healthy subjects. To evaluate the pharmacodynamic (PD) characteristics of YD6390 tablets after multiple oral administration in healthy subjects. To conduct an exploratory material balance study to investigate the cumulative excretion rate of the parent drug YD6390 in urine and feces, and to identify and analyze the metabolites in plasma, urine, and feces.