[Translation] A randomized, double-blind, placebo-controlled phase Ib clinical study evaluating the safety, tolerability and pharmacokinetics of continuous intravenous infusion of STC314 injection in Chinese patients with acute respiratory distress syndrome
主要目的:评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液的安全性与耐受性;评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液的药代动力学特征。
次要目的:初步评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液疗效。
探索性目的:探索静脉输注STC314注射液前后血液循环中组蛋白/NETs以及炎症因子相关指标的水平变化。
[Translation] Main purpose: To evaluate the safety and tolerability of continuous 72-hour intravenous infusion of STC314 injection in patients with acute respiratory distress syndrome; to evaluate the pharmacokinetics of STC314 injection for 72-hour continuous intravenous infusion in patients with acute respiratory distress syndrome.
Secondary objective: To preliminarily evaluate the efficacy of continuous 72-hour intravenous infusion of STC314 injection in patients with acute respiratory distress syndrome.
Exploratory purpose: To explore the changes in the levels of histone/NETs and inflammatory factors-related indicators in blood circulation before and after intravenous infusion of STC314 injection.