[Translation] A Phase I clinical study on the safety, tolerability, pharmacokinetics and pharmacodynamics of HSK39297 tablets in healthy subjects and the effect of food on pharmacokinetics
第一阶段(Part A): 单次给药阶段(SAD)
主要目的:评价 HSK39297 片在健康受试者中单次给药的安全性和耐受性;
次要目的:1. 评价 HSK39297 片在健康受试者中单次给药后的药代动力学(PK)和药效动力学(PD)特征;2. 评价食物对 HSK39297 片单次给药后药代动力学的影响;
探索性目的:1. 初步探索 HSK39297 在人体内的代谢产物鉴定和主要排泄途径, 考察尿液和粪便中 HSK39297 原形药物和代谢产物(如适用)的累积排泄率。2. 初步评估 HSK39297 片对 QT 间期的影响。
第二阶段(Part B):多次给药阶段(MAD)
主要目的:评价 HSK39297 片在健康受试者中多次给药的安全性和耐受性;
次要目的:评价 HSK39297 片在健康受试者中多次给药的药代动力学和药效动力学特征。
[Translation] Phase I (Part A): Single-dose administration phase (SAD)
Primary objective: To evaluate the safety and tolerability of a single dose of HSK39297 tablets in healthy subjects;
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HSK39297 tablets after a single dose in healthy subjects; 2. To evaluate the effect of food on the pharmacokinetics of HSK39297 tablets after a single dose;
Exploratory objectives: 1. To preliminarily explore the identification of metabolites and the main excretion pathways of HSK39297 in humans, and to investigate the cumulative excretion rate of HSK39297 parent drug and metabolites (if applicable) in urine and feces. 2. To preliminarily evaluate the effect of HSK39297 tablets on the QT interval.
Phase II (Part B): Multiple Dosing Phase (MAD)
Primary objective: To evaluate the safety and tolerability of HSK39297 tablets after multiple dosing in healthy subjects;
Secondary objective: To evaluate the pharmacokinetic and pharmacodynamic characteristics of HSK39297 tablets after multiple dosing in healthy subjects.