An Open-Label, Single-Arm, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Tolerability of SNE-101 in Patients With Acute Ischemic Stroke
This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke
• Adults with 19 years or older
• Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures.
• Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation.
• Imaging findings must meet both of the following:
‣ Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)
⁃ Infarct size ≥ 20 mm in the longest diameter on DWI
• Neurological status meeting all three of the following NIHSS criteria:
‣ Moderate to severe neurological deficit (NIHSS score between 5-21)
⁃ New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b)
⁃ No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c)
• Voluntary written informed consent