Evaluating BB-031 for patients with acute ischemic stroke
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
This study is testing a new drug called BB-031 to see if it is safe and helpful for people who have had an acute ischemic stroke within the last 24 hours.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Basking Biosciences, Inc. Industry-sponsored |
| Locations | 24 sites (Scottsdale, Arizona and 23 other locations) |
| Trial ID | NCT06226805 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the investigational drug BB-031 in patients diagnosed with acute ischemic stroke within 24 hours of symptom onset. It consists of two parts: the first part involves ascending doses of the drug to determine optimal dosing, while the second part involves a randomized comparison of selected doses against a placebo. A total of 156 participants will be followed for 90 days, with outcomes evaluated by a central blinded reviewer. The study is designed to provide insights into the drug's efficacy and safety profile in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of acute ischemic stroke and anterior circulation intra-cranial occlusion.
Not a fit: Patients with large volume ischemic strokes, prior strokes within 90 days, or those with significant bleeding risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from acute ischemic stroke.
How similar studies have performed: While this approach is novel in its specific application, similar studies evaluating treatments for acute ischemic stroke have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 23 other locations
- HonorHealth Bob Bove Neuroscience Institute — Scottsdale, Arizona, United States (Recruiting)
- Mills Peninsula Medical Center — Burlingame, California, United States (Withdrawn)
- MemorialCare Long Beach Medical Center — Long Beach, California, United States (Withdrawn)
- California Pacific Medical Center — San Francisco, California, United States (Withdrawn)
- Pacific Neurosciences Institute at Saint John's Physician Partners — Torrance, California, United States (Recruiting)
- Baptist Health Medical Center — Jacksonville, Florida, United States (Terminated)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
- WakeMed — Raleigh, North Carolina, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- ProMedica Toledo Hospital — Toledo, Ohio, United States (Recruiting)
- Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States (Recruiting)
- Valley Baptist Medical Center - Harlingen — Harlingen, Texas, United States (Recruiting)
- Memorial Hermann Hospital — Houston, Texas, United States (Recruiting)
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Monash Medical Centre — Clayton, Victoria, Australia (Recruiting)
- The Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (Recruiting)
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Michael D Hill, MD — University of Calgary
- Study coordinator: Program Director
- Email: snelson@baskingbiosciences.com
- Phone: 9196184721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.