[Translation] A randomized, double-blind, single-center Phase Ia study to evaluate the safety, tolerability, pharmacokinetics, and food effects of single and multiple doses of XT1061 in healthy subjects
主要目的:
(1)评价健康受试者在空腹条件下单次、多次服用XT1061的安全性和耐受性;
(2)评价健康受试者在空腹条件下单次、多次服用XT1061的药代动力学影响;
(3)评价食物对XT1061在健康受试者体内的药代动力学的影响。
次要目的:
(1)初步探索健康受试者在空腹条件下单次服用XT1061的代谢转化研究;
(2)评估高脂饮食对健康受试者服用XT1061的安全性的影响。
[Translation] Primary objectives:
(1) To evaluate the safety and tolerability of single and multiple doses of XT1061 in healthy subjects under fasting conditions;
(2) To evaluate the pharmacokinetic effects of single and multiple doses of XT1061 in healthy subjects under fasting conditions;
(3) To evaluate the effect of food on the pharmacokinetics of XT1061 in healthy subjects.
Secondary objectives:
(1) To preliminarily explore the metabolic transformation of XT1061 in healthy subjects after single doses of XT1061 under fasting conditions;
(2) To evaluate the effect of a high-fat diet on the safety of XT1061 in healthy subjects.