[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of a single oral dose of 1200 mg and 1600 mg MY008211A tablets in healthy Chinese volunteers
主要研究目的:评估中国健康志愿者单次口服MY008211A片1200mg和1600mg后的安全性、耐受性;
次要研究目的:评估中国健康志愿者单次口服MY008211A片1200mg和1600mg后的药代动力学特征;
探索性目的:探索MY008211A片在人体血浆中代谢产物的类型、药效动力学相关标志物水平及其与MY008211A片PK参数的关系。
[Translation] Primary study objective: To evaluate the safety and tolerability of MY008211A tablets 1200mg and 1600mg after a single oral administration in healthy Chinese volunteers;
Secondary study objective: To evaluate the pharmacokinetic characteristics of MY008211A tablets 1200mg and 1600mg after a single oral administration in healthy Chinese volunteers;
Exploratory objective: To explore the types of metabolites of MY008211A tablets in human plasma, the levels of pharmacodynamic-related markers, and their relationship with the PK parameters of MY008211A tablets.