Acute Ischemic Stroke

Primary Objective:To determine the safety of a single dose (0.025 mg/kg) of LT3001 drug product administered intravenously (IV) in subjects with acute ischemic stroke (AIS).Secondary Objectives:To determine the tolerability of a single dose (0.025 mg/kg) of LT3001 drug product administered IV in subjects with AIS.To determine the potential efficacy of a single dose (0.025 mg/kg) of LT3001 drug product administered IV in subjects with AIS.To determine the pharmacokinetic (PK) parameters of a single dose(0.025 mg/kg) of LT3001 drug product administered IV in subjects with AIS (subjects can opt to have PK sampling done or not).

LT3001 drug product

LT3001

injection

20mg

Primary Endpoint:
The occurrence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing; clinical deterioration defined as an increase in the National Institute of Health Stroke Scale (NIHSS) of 4 points or more AND confirmed by computed tomography (CT)- or magnetic resonance imaging (MRI)-documented.
Secondary Endpoints:
The occurrence of sICH within 7 days after dosing
The occurrence of asymptomatic ICH within 36 hours and 7 days after dosing
The occurrence of mortality due to intracerebral or other major bleeding complications within 24 hours, 7, 30, and 90 days after dosing
The occurrence of mortality due to any reason within 24 hours, 7, 30, and 90 days after dosing.
The number and severity of AEs within 90 days after dosing
The number of subjects with AEs within 90 days after dosing

1. Subject or subject’s legal representative must sign the informed consent form (ICF).
2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1).
3. Subject has a NIHSS of 4 to 30.
4. Subject has a clinical diagnosis of AIS within 24 hours after stroke symptoms onset.
5. Subject is able to have CT or MRI examination before any AIS treatment.
6. Subject is able to receive the investigational product within 24 hours after stroke symptoms onset.
7. Subjects are women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after dosing of investigational product.

1. Subject has been treated with recombinant tissue-type plasminogen activator (rtPA) and/or endovascular thrombectomy (EVT) during the current AIS.
2. Subject has a pre-stroke disability that requires help for activities of daily living (mRS≥2).
3. Subject has imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
4. Subject has Alberta Stroke Program Early CT Score (ASPECTS) of ≤4 or ischemic core volume >70 mL.
5. Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
6. Subject has generalized seizure at onset of the current AIS.
7. Subject has current uncontrolled hypertension despite treatment: systolic blood pressure >185 mmHg or diastolic blood pressure>110 mmHg before dosing.
8. Subject has International Normalized Ratio (INR) >1.7, abnormal activated partial thromboplastin time (aPTT) or platelet count <100,000/mm3.
9.Blood glucose concentration <50 mg/dL or >400 mg/dL
10. Subject is lactating, pregnant (pregnancy test required for all female subjects), or planning to become pregnant during the study.
11. Subject has received anticoagulants within 48 hours prior to treatment, e.g., direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban, edoxaban), low molecular weight heparin (e.g., enoxaparin), fondaparinux.
12. Subject has received oral double antiplatelet therapy and glycoprotein (GP) IIb/IIIa inhibitors within 48 hours prior to treatment, e.g., aspirin with clopidogrel or dipyridamole and abciximab, triofiban, eptifibatide.
13. Subject has had prior AIS, myocardial infarction, or serious head trauma within 90 days of Screening (Visit 1).
14. Subject has history of ICH within 90 days of Screening (Visit 1).
15. Subject has had any major surgery within 90 days of Screening (Visit 1), e.g., intracranial or intraspinal surgery, coronary artery bypass graft, obstetrical delivery, organ biopsy.
16. Subject with bleeding event within 21 days of Screening (Visit 1), e.g., gastrointestinal or hemorrhage.
17. Subject has puncture of noncompressible vessels within 7 days of Screening (Visit 1). (e.g. subclavian or jugular vein puncture, arterial puncture, or lumbar puncture within 7 days
18. Subject has severe hepatic, renal, and/or active infectious disease at Screening (Visit 1).
19. Subject has participated in another investigational study and received investigational product within 30 days of Screening (Visit 1) or 5 half-lives (whichever is longer).
20. In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.