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

Korábbi kezelés

• Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
• 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).

Más betegség

• Subject has a pre-stroke disability (mRS ≥2).
• 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 pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
• Subject has current uncontrolled hypertension despite treatment.
• Subject has moderate or severe hepatic, renal, and/or active infectious disease.

Laborértékek

• Subject has INR >1.7 or abnormal aPTT or platelet count <100,000/mm\^3.
• Subject has blood glucose concentration <50 mg/dL or >400 mg/dL.

Egyéb

• Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
• Subject has large ischemic core volume >70 mL or ASPECTS ≤5.
• Subject has significant mass effect with midline shift.
• Subject is lactating, pregnant, or planning to become pregnant during the study.
• In the opinion of the Investigator, the subject is not appropriate for the study.

• 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.