Phase 2 Completed N=24 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT04091945 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Dec 2025

Primary outcomePrimary: The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. — 0; 0 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.	0; 0	—

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04091945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.