[Translation] A randomized, double-blind, single-center phase I/IIa study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of single and multiple doses of XTYW007 tablets in healthy subjects and healthy subjects with elevated LDL-C.
主要目的:评价XTYW007片在健康受试者及健康受试者伴LDL-C升高受试者在空腹条件下单次、多次服用XTYW007片的安全性和耐受性;评价XTYW007片在健康受试者及健康受试者伴LDL-C升高受试者在空腹条件下单次、多次服用XTYW007片的药代动力学。
次要目的:评价健康受试者及健康受试者伴LDL-C升高受试者中单次、多次给药后药效学;评价食物对XTYW007片单次给药后的药代动力学的影响;初步探索空腹条件下单次服用XTYW007片的代谢转化研究。
[Translation] Primary Objective: To evaluate the safety and tolerability of XTYW007 tablets in healthy subjects and healthy subjects with elevated LDL-C under fasting conditions, including single and multiple administrations; to evaluate the pharmacokinetics of XTYW007 tablets in healthy subjects and healthy subjects with elevated LDL-C under fasting conditions, including single and multiple administrations.
Secondary Objectives: To evaluate the pharmacodynamics of XTYW007 tablets after single and multiple administrations in healthy subjects and healthy subjects with elevated LDL-C; to evaluate the effect of food on the pharmacokinetics of XTYW007 tablets after a single administration; and to conduct a preliminary study on the metabolic transformation of XTYW007 tablets after a single administration under fasting conditions.