[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial evaluating the efficacy and safety of different doses of injectable KPCXM18 in the treatment of acute ischemic stroke.
主要目的:
评价不同给药剂量的注射用KPCXM18治疗急性缺血性卒中的有效性。
次要目的:
评价不同给药剂量的注射用KPCXM18治疗急性缺血性卒中的安全性;
基于群体药代动力学(Pharmacokinetics, PK)分析方法,探索注射用KPCXM18在急性缺血性卒中患者中的PK特征,为Ⅲ期临床研究设计提供依据。
[Translation] Primary Objective: To evaluate the efficacy of different doses of injectable KPCXM18 in the treatment of acute ischemic stroke.
Secondary Objective: To evaluate the safety of different doses of injectable KPCXM18 in the treatment of acute ischemic stroke;
Based on population pharmacokinetic (PK) analysis, to explore the PK characteristics of injectable KPCXM18 in patients with acute ischemic stroke, providing a basis for the design of a phase III clinical trial.