[Translation] Evaluation of the safety, tolerability and pharmacokinetics of SGC-003 tablets in healthy subjects: a single-center, double-blind, randomized, placebo-controlled, dose-escalation Phase I clinical study
主要目的:评价在健康受试者中SGC-003片单次和多次递增口服给药的安全性和耐受性。
次要目的:(1)测定在健康受试者中SGC-003片单次和多次递增口服给药后不同时间的药物浓度,评估其药代动力学特征。(2)单次给药代谢产物的鉴定及初步的物料平衡评估。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple ascending oral administration of SGC-003 tablets in healthy subjects.
Secondary objectives: (1) To determine the drug concentrations at different times after single and multiple ascending oral administration of SGC-003 tablets in healthy subjects and evaluate its pharmacokinetic characteristics. (2) To identify metabolites after single administration and conduct preliminary material balance assessment.