Phase II Study of LT3001 Drug Product to Assess Safety and Effectiveness in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the LT3001 drug product in adults aged 18 to 90 years who have acute ischemic stroke AIS and are undergoing a procedure called endovascular thrombectomy EVT. This Phase IIb, double-blind, randomized, and placebo-controlled study compares LT3001 with a placebo to better understand its impact when added to standard stroke care. The study is sponsored by Lumosa Therapeutics Co., Ltd. Participants receive either the LT3001 drug product or a placebo administered once through an intravenous infusion before EVT. The study includes two parts and ensures participants also receive standard treatments for AIS when appropriate. The timing of treatment is within 24 hours after stroke symptom onset, with detailed brain imaging used to confirm eligibility. During the trial, participants undergo various assessments including brain imaging with MRI or CT scans, neurological exams measuring stroke severity with the NIH Stroke Scale, and monitoring for brain bleeding within 24 hours after dosing. Researchers track safety and clinical changes to evaluate the drugs effects. The total study duration and follow-up details are based on these evaluations, with careful oversight throughout the process.

A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT