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

A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)

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.

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