Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

What this study is about

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.

Who can join (things the study team will check)

✅ You may be able to join if…

• Clinical diagnosis of acute ischemic stroke
• 18 years or older
• Anterior circulation intra-cranial occlusion
• NIHSS score >3
• Onset of stroke symptoms within 24 hours of enrollment

🚫 You may not be able to join if…

• Large volume ischemic stroke
• Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
• Chronic intracranial occlusion
• Weight >125kg
• Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
• Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
• Prior stroke within 90 days
• Unable to undergo a contrast brain perfusion scan with either MRI or CT

Where this trial is running

• HonorHealth Bob Bove Neuroscience Institute, Scottsdale, Arizona, United States
• Mills Peninsula Medical Center, Burlingame, California, United States
• MemorialCare Long Beach Medical Center, Long Beach, California, United States
• California Pacific Medical Center, San Francisco, California, United States
• Pacific Neurosciences Institute at Saint John's Physician Partners, Torrance, California, United States
• Baptist Health Medical Center, Jacksonville, Florida, United States
• Henry Ford Hospital, Detroit, Michigan, United States
• Washington University in St. Louis, St Louis, Missouri, United States
• Cooper University Hospital, Camden, New Jersey, United States
• WakeMed, Raleigh, North Carolina, United States
• The Ohio State University, Columbus, Ohio, United States
• ProMedica Toledo Hospital, Toledo, Ohio, United States

+ 13 more sites.

Who to contact

Program Director · 9196184721 · snelson@baskingbiosciences.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06226805.