[Translation] Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of HW091077 tablets after multiple administration in healthy subjects, as well as the effect of food on its pharmacokinetics under single administration conditions
主要目的:(1)评价在健康受试者中HW091077多次递增口服给药的安全性和耐受性。
次要目的:(1)测定在健康受试者中HW091077多次递增口服给药后不同时间的药物浓度,评估其药代动力学特征;(2)评价单次给药条件下食物(高脂高热量餐)对HW091077药代动力学的影响
探索目的:(1)初步探索HW091077多次给药对受试者QT/QTc间期的影响。
[Translation] Primary objectives: (1) To evaluate the safety and tolerability of HW091077 after multiple ascending oral administration in healthy subjects.
Secondary objectives: (1) To determine the drug concentration at different times after multiple ascending oral administration of HW091077 in healthy subjects and evaluate its pharmacokinetic characteristics; (2) To evaluate the effect of food (high-fat and high-calorie meal) on the pharmacokinetics of HW091077 under single administration conditions
Exploratory objectives: (1) To preliminarily explore the effect of multiple administration of HW091077 on the QT/QTc interval of subjects.