[Translation] A phase I clinical study on the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics of HSK36357 capsules in healthy Chinese adult subjects
第一阶段(Part A):单次给药阶段(SAD)
主要目的:评价HSK36357胶囊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HSK36357胶囊在健康受试者中单次给药后的药代动力学特征;
2. 评价食物对HSK36357胶囊单次给药后药代动力学的影响;
探索性目的:
1. 初步探索HSK36357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HSK36357原形药物和代谢产物(如适用)的累积排泄率。
2. 初步评估HSK36357胶囊对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HSK36357胶囊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HSK36357胶囊在健康受试者中多次给药后的药代动力学特征。
[Translation] Phase I (Part A): Single-dose phase (SAD)
Main objective: To evaluate the safety and tolerability of single-dose HSK36357 capsules in healthy subjects;
Secondary objectives:
1. To evaluate the pharmacokinetic characteristics of HSK36357 capsules after single-dose in healthy subjects;
2. To evaluate the effect of food on the pharmacokinetics of HSK36357 capsules after single-dose;
Exploratory objectives:
1. To preliminarily explore the identification and main excretion pathways of HSK36357 metabolites in humans, and to investigate the cumulative excretion rates of HSK36357 parent drug and metabolites (if applicable) in urine and feces.
2. To preliminarily evaluate the effect of HSK36357 capsules on the QT interval.
Phase II (Part B): Multiple-dose phase (MAD)
Main objective: To evaluate the safety and tolerability of multiple-dose HSK36357 capsules in healthy subjects;
Secondary objectives: To evaluate the pharmacokinetic characteristics of HSK36357 capsules after multiple-dose in healthy subjects.