NCT06226805RecruitingPhase 2
Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 7 Jan 2024
- Start date
- 31 Jul 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Basking Biosciences, Inc.
- Diseases
- Stroke
- NCT number
- NCT06226805
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 228
- From 31 Jul 2024 to the primary completion date, Jun 2027
- 25 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
- Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
- Prior stroke within 90 days
Other illness
- 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
Other
- Chronic intracranial occlusion
- Weight \>125kg
- Unable to undergo a CTA or MRA
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Terminated |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| John Hunter Hospital Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Recruiting |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Vancouver Stroke Program Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Mills-Peninsula Medical Center Coordinator of this site? Confirm its status | Burlingame | United States | Withdrawn |
| Cooper University Hospital Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Valley Baptist Medical Center - Harlingen Coordinator of this site? Confirm its status | Harlingen | United States | Recruiting |
| Memorial Hermann Hospital Coordinator of this site? Confirm its status | Houston | United States | Terminated |
| Baptist Health Medical Center Coordinator of this site? Confirm its status | Jacksonville | United States | Terminated |
| MemorialCare Long Beach Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Withdrawn |
| Wakemed Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Withdrawn |
| HonorHealth Bob Bové Neuroscience Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Mercy Health St. Vincent Medical Center Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Pacific Neurosciences Institute at Saint John's Physician Partners Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.