[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the tolerability, safety, and pharmacokinetic characteristics of single and multiple intravenous infusions of YB211 in healthy Chinese adult subjects
主要目的:评估YB211在健康受试者中单次/多次静脉输注给药的安全性和耐受性。
次要目的:
(1)评估YB211在健康受试者中单次/多次静脉输注给药的药代动力学(PK)特征;
(2)评估YB211在健康受试者中单次静脉输注给药后血药浓度对QT/QTc间期的影响。
探索性目的:
(1)探索YB211在健康受试者中单次/多次静脉输注给药后早期肾损伤指标(肾损伤分子-1(KIM-1)、中性粒细胞明胶酶相关脂质运载蛋白(NGAL)、尿β2-微球蛋白(β2-MG))较基线的变化;
(2)探索YB211在健康受试者中单次静脉输注给药后可能的代谢产物及代谢途径。
[Translation] Primary objective: To evaluate the safety and tolerability of single/multiple intravenous infusions of YB211 in healthy subjects.
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of single/multiple intravenous infusions of YB211 in healthy subjects;
(2) To evaluate the effect of blood concentration of YB211 on QT/QTc interval after single intravenous infusion in healthy subjects.
Exploratory objectives:
(1) To explore the changes of early renal injury indicators (kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), urinary β2-microglobulin (β2-MG)) compared with baseline after single/multiple intravenous infusions of YB211 in healthy subjects;
(2) To explore the possible metabolites and metabolic pathways of YB211 after single intravenous infusion in healthy subjects.