[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial evaluating the safety, tolerability and pharmacokinetics of ASK0912 for injection in Chinese healthy subjects with single and multiple intravenous infusion dose escalation
主要目的:
评价注射用ASK0912在健康受试者中单剂、多剂静脉输注给药的安全性和耐受性。
次要目的:
评价注射用ASK0912在健康受试者中单剂、多剂静脉输注给药后的药代动力学特征。
探索性研究目的:
探索性分析注射用ASK0912单剂和多剂给药后,早期肾损伤指标较基线的变化。
探索性分析注射用ASK0912可能的代谢产物及代谢途径。
探索性分析注射用ASK0912单剂给药后,ASK0912的血浆药物浓度与QTC间期之间的量效关系。
[Translation] main purpose:
To evaluate the safety and tolerability of single-dose and multiple-dose intravenous infusion of ASK0912 for injection in healthy subjects.
Secondary purpose:
To evaluate the pharmacokinetics of ASK0912 for injection following single-dose and multiple-dose intravenous infusion administration in healthy subjects.
Exploratory research aims:
Exploratory analysis of changes from baseline in early renal injury markers after single and multiple doses of ASK0912 for injection.
Exploratory analysis of possible metabolites and metabolic pathways of ASK0912 for injection.
The dose-response relationship between the plasma drug concentration of ASK0912 and the QTC interval after single-dose administration of ASK0912 for injection was exploratively analyzed.