[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of WXSH0208 tablets in healthy Chinese subjects, with single-center, randomized, double-blind, placebo-controlled, single-ascending dosing, multiple dosing and food effects
主要目的:1)评估健康成人空腹条件下单次口服WXSH0208片后的安全性和耐受性。2)评估健康成人多次服用WXSH0208片后的安全性和耐受性。
次要目的:1)评估健康成人空腹条件下单次口服WXSH0208片后前药WXSH0208和母药WXSH0208-4的药代动力学特征。2)评估健康成人多次口服WXSH0208片后前药WXSH0208和母药WXSH0208-4的药代动力学特征。3)评估食物对健康成人口服WXSH0208片后前药WXSH0208和母药WXSH0208-4药代动力学特征的影响。
[Translation] Primary objectives: 1) To evaluate the safety and tolerability of a single oral dose of WXSH0208 tablets in healthy adults under fasting conditions. 2) To evaluate the safety and tolerability of WXSH0208 tablets in healthy adults after multiple doses.
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of prodrug WXSH0208 and parent drug WXSH0208-4 after a single oral dose of WXSH0208 tablets in healthy adults under fasting conditions. 2) To evaluate the pharmacokinetic characteristics of prodrug WXSH0208 and parent drug WXSH0208-4 after multiple oral doses of WXSH0208 tablets in healthy adults. 3) To evaluate the effect of food on the pharmacokinetic characteristics of prodrug WXSH0208 and parent drug WXSH0208-4 after oral administration of WXSH0208 tablets in healthy adults.