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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Basking Biosciences, Inc. • ClinicalTrials.gov ID: NCT06226805

Registry updated: 2026-10-13
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Description

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.

Interventions

  • BB-031 (Drug)
    Solution for injection
  • Placebo (Drug)
    0.9% sodium chloride for injection

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 CTA or MRA * Known severe renal disease * Known hypersensitivity to any constituent of BB-031

Conditions

Acute Ischemic Stroke

Locations

  • 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
  • Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States
  • Valley Baptist Medical Center - Harlingen — Harlingen, Texas, United States
  • Memorial Hermann Hospital — Houston, Texas, United States
  • John Hunter Hospital — New Lambton Heights, New South Wales, Australia
  • Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
  • Royal Adelaide Hospital — Adelaide, South Australia, Australia
  • Monash Medical Centre — Clayton, Victoria, Australia
  • The Royal Melbourne Hospital — Parkville, Victoria, Australia
  • Fiona Stanley Hospital — Murdoch, Western Australia, Australia
  • University of Calgary — Calgary, Alberta, Canada
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • Vancouver Stroke Program — Vancouver, British Columbia, Canada
  • Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record