NCT06226805 Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
| NCT ID | NCT06226805 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Basking Biosciences, Inc. |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 228 participants in total. It began in 2024-07-31 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 contrast brain perfusion scan with either MRI or CT
Contact & Investigator
Michael D Hill, MD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT06226805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06226805 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06226805 currently recruiting?
Yes, NCT06226805 is actively recruiting participants. Contact the research team at snelson@baskingbiosciences.com for enrollment information.
Where is the NCT06226805 trial being conducted?
This trial is being conducted at Scottsdale, United States, Burlingame, United States, Long Beach, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT06226805 clinical trial?
NCT06226805 is sponsored by Basking Biosciences, Inc.. The principal investigator is Michael D Hill, MD at University of Calgary. The trial plans to enroll 228 participants.
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