[Translation] A clinical pharmacology trial evaluating the safety, tolerability, and pharmacokinetics of KSP-1007-05 combined with meropenem in healthy Japanese males and Chinese males and females
主要目的: 研究日本健康成年男性、中国健康成年男性和女性接受KSP-1007-05联合美罗培南多次静脉输注时,KSP-1007-05的安全性和耐受性。次要目的: 研究日本健康成年男性、中国健康成年男性和女性接受KSP-1007-05联合美罗培南多次静脉输注时,KSP-1007和美罗培南的血浆药代动力学和尿排泄特征。探索性目的: 研究日本健康成年男性、中国健康成年男性和女性接受KSP-1007-05联合美罗培南多次静脉输注时,对肾脏的影响。
[Translation] Primary Objective: To investigate the safety and tolerability of KSP-1007-05 combined with meropenem after multiple intravenous infusions in healthy Japanese males, healthy Chinese males, and females. Secondary Objective: To investigate the plasma pharmacokinetics and urinary excretion characteristics of KSP-1007 and meropenem after multiple intravenous infusions in healthy Japanese males, healthy Chinese males, and females. Exploratory Objective: To investigate the renal effects of KSP-1007-05 combined with meropenem after multiple intravenous infusions in healthy Japanese males, healthy Chinese males, and females.