Phase 2
N=24
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04091945 ↗Enrolled (actual)
24
Serious AEs
25.0%
Results posted
Dec 2025
Primary outcome: Primary: The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LT3001 Drug Product (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lumosa Therapeutics Co., Ltd.
- Primary completion
- Feb 2021
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 | — |
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.
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
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.