[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety and tolerability of HRN01 tablets in healthy subjects
主要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的安全性、耐受性;
2.评价食物(高脂高热量餐)对HRN01片药代动力学的影响。
次要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的药代动力学特征;
2.评价HRN01片在健康受试者中的代谢与排泄特征;
3.评价HRN01片单次给药后对健康受试者QTc间期的影响;
4.评价健康受试者在餐后状态下(高脂高热量餐)口服HRN01片的安全性和耐受性。
探索性目的:
探索在健康受试者中多次口服HRN01片后的药效学指标。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the effect of food (high-fat and high-calorie meal) on the pharmacokinetics of HRN01 tablets.
Secondary objectives:
1. To evaluate the pharmacokinetic characteristics of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the metabolism and excretion characteristics of HRN01 tablets in healthy subjects;
3. To evaluate the effect of single administration of HRN01 tablets on the QTc interval of healthy subjects;
4. To evaluate the safety and tolerability of oral administration of HRN01 tablets in healthy subjects in the postprandial state (high-fat and high-calorie meal).
Exploratory objectives:
To explore the pharmacodynamic indicators of HRN01 tablets after multiple oral administration in healthy subjects.