A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant

Korábbi kezelés

• Participant has received one of the new oral anticoagulants within 48 hours before the 1st IP administration, e.g., dabigatran, apixaban, rivaroxaban, and edoxaban, except for dabigatran-treated participant who has been given a reversal agent, idarucizumab, before the 1st IP administration.
• Participant has history of sICH, prior AIS, myocardial infarction, serious head trauma, or any major surgery within 90 days before Screening (Visit 1).
• Participant has had a bleeding event within 21 days before Screening (Visit 1), e.g., gastrointestinal hemorrhage.
• Participant has puncture of noncompressible vessels within 7 days before Screening (Visit 1).
• Participant has participated in another investigational study and received investigational product within 30 days before Screening (Visit 1) or 5 half-lives (whichever is longer).

Más betegség

• Participant has a pre-stroke disability that requires help for activities of daily living (mRS >2).
• Participant has Alberta Stroke Program Early CT Score (ASPECTS) of <5.
• Participant has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
• Participant has imaging evidence of acute intracranial hemorrhage, intracranial tumor (except small meningioma), arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
• Participant has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations, e.g., seizures at onset of the current AIS, dementia.
• Participant has current uncontrolled hypertension despite treatment: systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg before dosing at Screening (Visit 1).
• Participant has moderate or severe hepatic, renal, and/or active infectious disease at Screening (Visit 1) as judged by the investigator. Participant with confirmed COVID-19 or influenza infection can be enrolled at the Investigator's discretion.
• In the opinion of the Investigator, the participant has serious, advanced, or terminal illness that will prevent improvement or follow-up visits.

Laborértékek

• Participant has hemorrhagic diathesis, coagulation factor deficiency or recent oral anticoagulant therapy with International Normalized Ratio (INR) >1.7 or activated partial thromboplastin time (aPTT) >3 times of upper limit of normal range at Screening (Visit 1).
• Participant has platelet count <100,000/mm3 at Screening (Visit 1).
• Participant has blood glucose concentration <50 mg/dL or >400 mg/dL at Screening (Visit 1).

Egyéb

• Participant has AOL =3 at Screening (Visit 1).
• Participant has significant mass effect with midline shift.
• Participant is lactating, pregnant (pregnancy test required for all female participants of childbearing potential), or planning to become pregnant during the study.
• In the opinion of the Investigator, the participant is not appropriate for the study for any other reason.

• Participant or participant's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
• Participant is aged 18 to 88 years, inclusive, at the time of Screening (Visit 1).
• Participant is not to be treated with intravenous thrombolytic (e.g., recombinant tissue-type plasminogen activator) treatment or endovascular thrombectomy (EVT)
• Participant has NIHSS of 6 to 23.
• Participant is able to receive the 1st IP within 24 hours after stroke symptoms onset.
• Participants who 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 last dosing of IP. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
  • Neuroimaging Inclusion Criteria:
• Participant is willing and able to undergo brain computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
  • No known history of severe contrast allergy, anaphylactoid reaction, or other clinical conditions that contraindicate contrast agent administration for CTA or MRA
  • Must not have MRI contraindications such as non-MRI-compatible pacemakers, cochlear implants, ferromagnetic implants/devices, claustrophobia, or other conditions preventing safe MRI scanning
• Participant is confirmed to have an acute intracranial arterial occlusion.