[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple intravenous infusions of ASK0912 for injection in healthy Chinese subjects
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] Primary objective:
To evaluate the safety and tolerability of single-dose and multiple-dose intravenous infusion of ASK0912 for injection in healthy subjects.
Secondary objective:
To evaluate the pharmacokinetic characteristics of single-dose and multiple-dose intravenous infusion of ASK0912 for injection in healthy subjects.
Purpose of exploratory study:
To explore the changes of early renal injury indicators compared with baseline after single-dose and multiple-dose administration of ASK0912 for injection.
To explore the possible metabolites and metabolic pathways of ASK0912 for injection.
To explore the dose-effect relationship between plasma drug concentration of ASK0912 and QTC interval after single-dose administration of ASK0912 for injection.