[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study of the safety, tolerability and pharmacokinetics of BEBT-503 in healthy Chinese subjects after single ascending dose (SAD) and multiple ascending dose (MAD)
主要目的:评价BEBT-503在中国健康受试者中单次和多次给药的安全性和耐受性,并与在澳大利亚开展的Ⅰ期临床试验的安全性结果分析比较;
次要目的:评价BEBT-503单次给药以及多次给药在健康受试者血浆中的药代动力学特征,同时与在澳大利亚开展的Ⅰ期临床试验的药代动力学结果分析比较;鉴别和测定血浆中BEBT-503的代谢产物。
[Translation] Primary objective: To evaluate the safety and tolerability of BEBT-503 in healthy Chinese subjects after single and multiple administrations, and to compare the safety results with those of the Phase I clinical trial conducted in Australia;
Secondary objective: To evaluate the pharmacokinetic characteristics of BEBT-503 in plasma of healthy subjects after single and multiple administrations, and to compare the pharmacokinetic results with those of the Phase I clinical trial conducted in Australia; to identify and determine the metabolites of BEBT-503 in plasma.