Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
Lead Sponsor:
Lumosa Therapeutics Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
Detailed Description
This is a multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS. The study is ...
Eligibility Criteria
Inclusion
- Subject is aged 18 to 90 years.
- Subject has an NIHSS of 6 to 25.
- Subject is able to receive the first IP within 24 hours after stroke symptoms onset.
- Neuroimaging
- Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
- Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL.
Exclusion
- Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
- Subject has a pre-stroke disability (mRS ≥2).
- Subject has large ischemic core volume \>70 mL or ASPECTS ≤5.
- Subject has symptoms of suspected subarachnoid hemorrhage.
- Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
- Subject has significant mass effect with midline shift.
- Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
- Subject has current uncontrolled hypertension despite treatment.
- Subject has INR \>1.7 or abnormal aPTT or platelet count \<100,000/mm\^3.
- Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
- Subject has blood glucose concentration \<50 mg/dL or \>400 mg/dL.
- Subject has moderate or severe hepatic, renal, and/or active infectious disease.
- Subject is lactating, pregnant, or planning to become pregnant during the study.
- Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening.
- Subject has had any major surgery within 90 days before Screening.
- Subject has had a bleeding event within 21 days before Screening.
- Subject has puncture of noncompressible vessels within 7 days before Screening.
- Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer).
- In the opinion of the Investigator, the subject is not appropriate for the study.
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05403866
Start Date
August 17 2022
End Date
May 23 2025
Last Update
December 26 2025
Active Locations (1)
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1
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States, 37403