NCT05198323

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

A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Lumosa Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT).

Detailed description

This is a 2-part, multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS undergoing EVT. Subjects who participate in this trial should be treated with standard of care (SoC) of AIS therapies when appropriate.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	LT3001 Drug Product	LT3001 Drug Product administered once by intravenous infusion
DRUG	Placebo	Placebo administered once by intravenous infusion

Timeline

• Start date: 2022-08-11
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-01-20
• Last updated: 2025-06-05

Locations

2 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study