[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose ascending phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and food effects of oral SG1001 tablets in healthy Chinese adult subjects
主要目的:
评估SG1001片在健康成年受试者中单次和多次给药的安全性和耐受性。
次要目的:
评估SG1001片在健康成年受试者中单次和多次给药的药代动力学(PK)特征。
评估食物对单次口服SG1001片后PK的影响。
探索性目的:
鉴定SG1001片在健康成年受试者中的代谢产物,并初步探索代谢物的相对丰度。
[Translation] Primary objective:
To evaluate the safety and tolerability of SG1001 tablets after single and multiple administration in healthy adult subjects.
Secondary objective:
To evaluate the pharmacokinetic (PK) characteristics of SG1001 tablets after single and multiple administration in healthy adult subjects.
To evaluate the effect of food on the PK after a single oral administration of SG1001 tablets.
Exploratory objective:
To identify the metabolites of SG1001 tablets in healthy adult subjects and preliminarily explore the relative abundance of metabolites.