[Translation] A randomized, double-blind, placebo-controlled, dose-escalation, single and multiple-dose Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of WXWH0075 for injection in healthy Chinese subjects
主要目的:
评估WXWH0075在健康受试者中单次/多次静脉滴注给药的安全性和耐受性
次要目的:
评估WXWH0075在健康受试者单次/多次静脉滴注给药的药代动力学特征
探索性目的:
探索WXWH0075在健康受试者中单次静脉滴注给药后对受试者QT/QTc间期的影响
探索WXWH0075 在健康受试者中单次静脉滴注给药后可能的代谢产物及代谢途径
探索WXWH0075在健康受试者中单次及多次静脉滴注给药后,早期肾损伤指标较基线的变化
[Translation] Primary purpose:
Evaluate the safety and tolerability of single/multiple intravenous infusions of WXWH0075 in healthy subjects
Secondary purpose:
Evaluate the pharmacokinetic characteristics of single/multiple intravenous infusions of WXWH0075 in healthy subjects
Exploratory purpose:
Explore the effect of single intravenous infusion of WXWH0075 on the QT/QTc interval of subjects in healthy subjects
Explore the possible metabolites and metabolic pathways of WXWH0075 after single intravenous infusion in healthy subjects
Explore the changes of early renal injury indicators compared with baseline after single and multiple intravenous infusions of WXWH0075 in healthy subjects