[Translation] A single-center, randomized, double-blind, single and multiple-dose, dose-escalation, placebo-controlled clinical trial to evaluate the tolerability and pharmacokinetics of SZ1108 tablets in healthy Chinese subjects
主要目的:评价SZ1108片在中国健康受试者中单次与多次口服给药的安全性及耐受性;次要目的:(1)评价SZ1108片在中国健康受试者中单次与多次给药的药代动力学(PK)特性,为后续临床试验设计提供依据。(2)采集粪便样本开展SZ1108对肠道微生态影响的探索性研究。
[Translation] Primary objectives: To evaluate the safety and tolerability of single and multiple oral administration of SZ1108 tablets in Chinese healthy subjects; Secondary objectives: (1) To evaluate the pharmacokinetic (PK) properties of single and multiple oral administration of SZ1108 tablets in Chinese healthy subjects to provide a basis for the design of subsequent clinical trials. (2) To collect fecal samples to conduct an exploratory study on the effect of SZ1108 on intestinal microecology.