[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of SK-08 tablets in healthy subjects with single ascending doses
主要目的:
评估SK-08片在中国健康受试者中单剂量递增给药后的安全性和耐受性。
次要目的:
1)评估SK-08片在中国健康受试者中单剂量递增给药后的药代动力学(PK)特征。
2)评估食物(高脂高热量餐)对SK-08片的PK特征的影响。
3)初步评价SK-08人体代谢、排泄特征。
4)评估不同剂量的SK-08片在单次给药下对QT间期的影响。
5)初步探索SK-08片在单次给药后的药效学(PD)特征。
[Translation] Primary objectives:
To evaluate the safety and tolerability of SK-08 tablets after single-dose ascending administration in healthy Chinese subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of SK-08 tablets after single-dose ascending administration in healthy Chinese subjects.
2) To evaluate the effect of food (high-fat and high-calorie meal) on the PK characteristics of SK-08 tablets.
3) To preliminarily evaluate the metabolism and excretion characteristics of SK-08 in humans.
4) To evaluate the effect of different doses of SK-08 tablets on the QT interval under single administration.
5) To preliminarily explore the pharmacodynamic (PD) characteristics of SK-08 tablets after single administration.