[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study of the safety, tolerability and pharmacokinetics of BEBT-503 in Chinese healthy subjects with 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液样本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;鉴别和测定血液样本中BEBT-503的代谢产物。
[Translation] Primary objective: To evaluate the safety and tolerability of BEBT-503 after single and multiple administration in healthy Chinese subjects, and to compare with the safety results of the Phase I clinical trial conducted in Australia;
Secondary objective: To evaluate the pharmacokinetic characteristics of BEBT-503 after single and multiple administration in blood samples of healthy subjects, and to compare with the pharmacokinetic results of the Phase I clinical trial conducted in Australia; to identify and measure the metabolites of BEBT-503 in blood samples.