[Translation] Phase I clinical study of the safety, tolerability, food effect and pharmacokinetics of DA414 granules after single/multiple administration in healthy subjects
(1)评估DA414颗粒在中国健康受试者中单次递增口服给药的安全性和耐受性;
(2)评估DA414颗粒在中国健康受试者中多次递增口服给药的安全性和耐受性;
(3)评估DA414颗粒在中国健康受试者中单次递增口服给药后的药代动力学(PK)特征;
(4)评估食物(高脂高热量餐)对健康受试者单次口服DA414颗粒后PK的影响;
(5)评估DA414颗粒在中国健康受试者中多次递增口服给药后的PK特征;
(6)评估不同剂量DA414颗粒在单次/多次给药条件下对受试者QT间期的影响。
[Translation] (1) To evaluate the safety and tolerability of DA414 granules after single-ascending oral administration in healthy Chinese subjects;
(2) To evaluate the safety and tolerability of DA414 granules after multiple-ascending oral administration in healthy Chinese subjects;
(3) To evaluate the pharmacokinetic (PK) characteristics of DA414 granules after single-ascending oral administration in healthy Chinese subjects;
(4) To evaluate the effect of food (high-fat and high-calorie meal) on the PK of DA414 granules after single oral administration in healthy subjects;
(5) To evaluate the PK characteristics of DA414 granules after multiple-ascending oral administration in healthy Chinese subjects;
(6) To evaluate the effect of different doses of DA414 granules on the QT interval of subjects under single/multiple administration conditions.