[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of SZEY-2108 for injection in healthy Chinese adult subjects using a randomized, double-blind, placebo-controlled, single-dose and multiple-dose ascending intravenous infusion
主要目的:
评估注射用SZEY-2108在健康受试者中单剂和多剂静脉输注的安全性和耐受性。
次要目的:
1) 评估注射用SZEY-2108在健康受试者中单剂和多剂静脉输注的药代动力学特征。
2)评估健康受试者单剂静脉输注注射用SZEY-2108后的暴露量对其QT/QTc间期的影响。
探索性目的:
分析健康受试者注射SZEY-2108后各生物基质(血、尿、粪便)中的代谢产物和排泄特征(粪便)。
[Translation] Primary objective:
To evaluate the safety and tolerability of single and multiple intravenous infusions of SZEY-2108 for injection in healthy subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of single and multiple intravenous infusions of SZEY-2108 for injection in healthy subjects.
2) To evaluate the effect of exposure after a single intravenous infusion of SZEY-2108 for injection on the QT/QTc interval in healthy subjects.
Exploratory objectives:
To analyze the metabolites and excretion characteristics (feces) in various biological matrices (blood, urine, feces) after injection of SZEY-2108 in healthy subjects.