[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics of HSK44459 tablets in healthy subjects
主要目的:评价 HSK44459 片在健康受试者中单次和多次给药的安全性和耐受性。
次要目的:
1.评价 HSK44459 片在健康受试者中单次和多次给药后的药代动力学(PK)特征;
2.评价食物对 HSK44459 片单次给药后药代动力学的影响。
探索性目的
1.初步探索 HSK44459 在人体内的代谢产物和主要排泄途径,考察尿液和粪便中 HSK44459 原形药物和代谢产物(如适用)的累积排泄率;
2.探索HSK44459 片在健康受试者中单次和多次给药后的药效动力学(PD)特征;
3.初步评估 HSK44459 片对 QT 间期的影响。次给药后药代动力学的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of HSK44459 tablets after single and multiple administration in healthy subjects.
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of HSK44459 tablets after single and multiple administration in healthy subjects;
2. To evaluate the effect of food on the pharmacokinetics of HSK44459 tablets after single administration.
Exploratory objectives
1. To preliminarily explore the metabolites and main excretion pathways of HSK44459 in humans, and investigate the cumulative excretion rate of HSK44459 parent drug and metabolites (if applicable) in urine and feces;
2. To explore the pharmacodynamic (PD) characteristics of HSK44459 tablets after single and multiple administration in healthy subjects;
3. To preliminarily evaluate the effect of HSK44459 tablets on the QT interval. The effect of pharmacokinetics after single administration.