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

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lumosa Therapeutics Co., Ltd.

Criteria

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