[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single and multiple ascending doses of HP515 tablets in healthy subjects
主要目的
1. 评价HP515片在健康受试者中单次及多次口服给药的安全性和耐受性;
2. 评价食物在健康受试者中对HP515片药代动力学的影响。
次要目的
1. 评价HP515片在健康受试者中单次及多次口服给药的药代动力学特征;
2. 评价HP515片在健康受试者中单次及多次口服给药的药效动力学特征;
探索性目的
探索口服HP515后血浆中的可能的代谢产物及主要代谢产物浓度(如有)。
[Translation] Main purpose
1. To evaluate the safety and tolerability of single and multiple oral administration of HP515 tablets in healthy subjects;
2. To evaluate the effect of food on the pharmacokinetics of HP515 tablets in healthy subjects.
Secondary purpose
1. To evaluate the pharmacokinetic characteristics of single and multiple oral administration of HP515 tablets in healthy subjects;
2. To evaluate the pharmacodynamic characteristics of single and multiple oral administration of HP515 tablets in healthy subjects;
Exploratory purpose
To explore the possible metabolites and the concentration of major metabolites (if any) in plasma after oral administration of HP515.