Tests BB-031 in adults with acute ischemic stroke
Tests BB-031 or placebo in adults treated within 24 hours of stroke onset.
Plain-language title generated from the registry record
Registry title: Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
Key facts
- Where
- Burlingame, Camden, Columbus, Detroit, Harlingen, Houston, Jacksonville, Long Beach, Raleigh, San Francisco, Scottsdale, St Louis, Toledo, and Torrance, United StatesSee the 15 sites
- Phase
- Phase 2
Where in United States
- Mills-Peninsula Medical CenterBurlingame, United StatesNo longer taking part
- Cooper University HospitalCamden, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Valley Baptist Medical Center - HarlingenHarlingen, United StatesTaking people
- Memorial Hermann HospitalHouston, United StatesNo longer taking part
- Baptist Health Medical CenterJacksonville, United StatesNo longer taking part
- MemorialCare Long Beach Medical CenterLong Beach, United StatesNo longer taking part
- WakemedRaleigh, United StatesTaking people
- California Pacific Medical CenterSan Francisco, United StatesNo longer taking part
- HonorHealth Bob Bové Neuroscience InstituteScottsdale, United StatesTaking people
- Washington University in St. LouisSt Louis, United StatesTaking people
- Mercy Health St. Vincent Medical CenterToledo, United StatesTaking people
- ProMedica Toledo HospitalToledo, United StatesTaking people
- Pacific Neurosciences Institute at Saint John's Physician PartnersTorrance, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Basking Biosciences, Inc.
- Trial code
- NCT06226805
- Record updated
- 13 October 2026
- Original 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.Read full original descriptionShow less
A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients
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.
Inclusion: 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: Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage; Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors; Prior stroke within 90 days; Large volume ischemic stroke; Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding; Known severe renal disease; Known hypersensitivity to any constituent of BB-031; Chronic intracranial occlusion; Weight >125kg; Unable to undergo a CTA or MRA.