[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of SN1011 in healthy subjects
主要目的:评价SN1011在中国健康成年受试者中单次和多次给药后的安全性和耐受性;
次要目的:评估SN1011单次和多次口服给药后的药代动力学(PK)特征;
探索性目的:探索SN1011单次和多次口服给药后的药效动力学(PD)特征;探索单次和多次口服给药后SN1011的 PK/PD 相关性;探索SN1011给药后血浆中SN1011的代谢物类型及主要代谢物的药代动力学特征(如适用)。
[Translation] Main objective: To evaluate the safety and tolerability of SN1011 after single and multiple doses in healthy Chinese adult subjects;
Secondary objective: To evaluate the pharmacokinetic (PK) profile of SN1011 following single and multiple oral administrations;
Exploratory purposes: To explore the pharmacodynamic (PD) characteristics of SN1011 after single and multiple oral administrations; to explore the PK/PD correlation of SN1011 after single and multiple oral administrations; to explore the plasma levels of SN1011 after administration Types of metabolites of SN1011 and pharmacokinetic profile of major metabolites (if applicable).