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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT06226805

Run by

Basking Biosciences, Inc.

People needed

228

Starts

2024-07-31

Expected to finish

2027-09-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• University of Calgary — Calgary, Alberta, Canada (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Vancouver Stroke Program — Vancouver, British Columbia, Canada (enrolling)
• HonorHealth Bob Bove Neuroscience Institute — Scottsdale, Arizona, United States (enrolling)
• Pacific Neurosciences Institute at Saint John's Physician Partners — Torrance, California, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• WakeMed — Raleigh, North Carolina, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• ProMedica Toledo Hospital — Toledo, Ohio, United States (enrolling)
• Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States (enrolling)
• Valley Baptist Medical Center - Harlingen — Harlingen, Texas, United States (enrolling)
• Memorial Hermann Hospital — Houston, Texas, United States (enrolling)
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
• The Royal Melbourne Hospital — Parkville, Victoria, Australia (enrolling)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
• 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
• Baptist Health Medical Center — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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