Phase 2 Trial to Test Different Doses of KPCXM18 Injection for Treating Acute Ischemic Stroke Randomized, Double-Blind, Placebo-Controlled Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the KPCXM18 injection at different doses for treating acute ischemic stroke. This phase 2 clinical trial uses a multicenter, randomized, double-blind, parallel, placebo-controlled design to compare treatments. The goal is to provide evidence for future studies and understand how the drug behaves in the body through population pharmacokinetic analysis. Participants are assigned to one of three groups a low-dose KPCXM18 injection group receiving 60 mg twice daily, a high-dose group receiving 100 mg twice daily, or a placebo group. All treatments are given by intravenous infusion every 12 hours for about 12 days. Researchers will observe and compare the effects of these doses against placebo to assess benefits and safety. During the study, participants will be monitored closely with assessments including the Modified Rankin Scale to measure disability at days 12, 30, and 90. Additional evaluations include stroke severity using the NIH Stroke Scale and daily functioning by the Barthel Index. The trial spans about three months of follow-up after treatment, with safety and effectiveness tracked throughout. Participants will be involved in regular visits to measure their recovery progress and any side effects.

Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke