A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects

Study Overview
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Brief Summary
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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
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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 planned to take place in multiple countries. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.

Official Title
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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)

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: LT3001 Drug Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LT3001 Drug Product<br>Administered by intravenous infusion | Drug: LT3001 Drug Product<br>* Administered by intravenous infusion<br>|
| Placebo Comparator: Placebo<br>Administered by intravenous infusion | Drug: Placebo<br>* Administered by intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with Adverse Events (AEs), judged to be probably or definitely related to the investigational product (IP), within 90 days after the first IP administration. |  | within 90 days after the first IP administration |