NCT05403866

A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Lumosa Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)

Detailed description

This is a multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS. The study is planned to take place in multiple countries. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	LT3001 Drug Product	Administered by intravenous infusion
DRUG	Placebo	Administered by intravenous infusion

Timeline

• Start date: 2022-08-17
• Primary completion: 2025-05-23
• Completion: 2025-05-23
• First posted: 2022-06-03
• Last updated: 2025-12-26
• Results posted: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study