[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single and multiple doses of YD0293 tablets in healthy subjects
主要目的:评价YD0293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YD0293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YD0293片的PK特征的影响;探索YD0293片对健康受试者QT/QTc间期的影响;评价YD0293片在健康受试者中多次口服给药后中性粒细胞弹性蛋白酶(NE)浓度较基线的变化。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple oral administration of YD0293 tablets in healthy subjects. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of YD0293 tablets in healthy subjects after single and multiple oral administration; to evaluate the effect of food on the PK characteristics of YD0293 tablets in healthy subjects; to explore the effect of YD0293 tablets on the QT/QTc interval in healthy subjects; to evaluate the changes in neutrophil elastase (NE) concentration compared with baseline after multiple oral administration of YD0293 tablets in healthy subjects.