[Translation] A Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of JKN2502 in healthy participants in China and in patients with renal impairment.
第一部分研究目的:
主要目的:评价JKN2502在中国健康试验参与者中静脉输注给药的安全性和耐受性。
次要目的:1)评价JKN2502在中国健康试验参与者中静脉输注给药的药代动力学特征;2)评价中国健康试验参与者接受JKN2502静脉输注给药后血药浓度对QT/QTc间期的影响。
探索性目的:初步分析JKN2502在血浆、尿液和粪便中的代谢产物。
第二部分研究目的:
主要目的:评估单次静脉输注JKN2502在肾功能正常及不同程度肾功能损害试验参与者中的药代动力学特征;
次要目的:评价静脉输注JKN2502在肾功能正常及轻、中、重度肾功能损害的试验参与者中的安全性和耐受性。
探索性目的:探索JKN2502药代动力学参数与肾功能指标(如eGFR、血肌酐等)之间的相关性。
[Translation] Part I: Study Objectives
Primary Objective: To evaluate the safety and tolerability of JKN2502 administered intravenously in healthy participants in the Chinese trial.
Secondary Objectives: 1) To evaluate the pharmacokinetic characteristics of JKN2502 administered intravenously in healthy participants in the Chinese trial; 2) To evaluate the effect of plasma drug concentration on the QT/QTc interval after intravenous administration of JKN2502 in healthy participants in the Chinese trial.
Exploratory Objective: To preliminarily analyze the metabolites of JKN2502 in plasma, urine, and feces.
Part II: Study Objectives
Primary Objective: To evaluate the pharmacokinetic characteristics of a single intravenous infusion of JKN2502 in participants with normal renal function and varying degrees of renal impairment.
Secondary Objective: To evaluate the safety and tolerability of intravenous infusion of JKN2502 in participants with normal renal function and mild, moderate, and severe renal impairment.
Exploratory Objective: To explore the correlation between pharmacokinetic parameters of JKN2502 and renal function indicators (such as eGFR, serum creatinine, etc.).