A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Phase 2

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: LT3001 Drug Product; Drug: Placebo

• Registration Number: NCT04091945
• Lead Sponsor: Lumosa Therapeutics Co., Ltd.

Brief Summary

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2020-01-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 18 to 90 years
• NIHSS of 4 to 30
• Diagnosis of AIS within 24 hours after stroke symptoms onset

Exclusion Criteria

• Treatement with approved drug during the current AIS
• Pre-stroke disability
• Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
• Suspected subarachnoid hemorrhage
• Seizure
• Uncontrolled hypertension
• INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3
• Blood glucose concentration <50 mg/dL or >400 mg/dL
• Lactating or pregnant subjects or those planning to become pregnant during the study
• Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
• AIS, myocardial infarction, serious head trauma or major surgery within 90 days
• Bleeding event within 21 days
• Puncture of noncompressible vessels within 7 days
• Severe hepatic, renal, and/or infectious disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LT3001 Drug Product	LT3001 Drug Product	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The percentage of subject have symptomatic intracranial hemorrhage (sICH) of a single dose LT3001 drug product in subjects with AIS.	Within 36 hours	Compare the the percentage of subject having symptomatic intracranial hemorrhage (sICH) between LT3001 drug product and Placebo.

Trial Locations

Locations (10)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Chattanooga Center for Neurologic Research; 🇺🇸 Chattanooga, Tennessee, United States

JFK Neuroscience Institute, JFK Medical Center; 🇺🇸 Edison, New Jersey, United States

University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Taipei Medical University - Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

The Ohio State University - Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States