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
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
HonorHealth Bob Bove Neuroscience Institute
RECRUITING
Scottsdale
California
Mills Peninsula Medical Center
WITHDRAWN
Burlingame
MemorialCare Long Beach Medical Center
WITHDRAWN
Long Beach
California Pacific Medical Center
WITHDRAWN
San Francisco
Pacific Neurosciences Institute at Saint John's Physician Partners
RECRUITING
Torrance
Florida
Baptist Health Medical Center
TERMINATED
Jacksonville
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Missouri
Washington University in St. Louis
RECRUITING
St Louis
North Carolina
WakeMed
RECRUITING
Raleigh
New Jersey
Cooper University Hospital
RECRUITING
Camden
Ohio
The Ohio State University
RECRUITING
Columbus
Mercy Health St. Vincent Medical Center
RECRUITING
Toledo
ProMedica Toledo Hospital
RECRUITING
Toledo
Texas
Valley Baptist Medical Center - Harlingen
RECRUITING
Harlingen
Memorial Hermann Hospital
RECRUITING
Houston
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Monash Medical Centre
RECRUITING
Clayton
Fiona Stanley Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
The Royal Melbourne Hospital
RECRUITING
Parkville
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Canada
University of Calgary
RECRUITING
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Contact Information
Primary
Program Director
snelson@baskingbiosciences.com
9196184721
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2027-09
Participants
Target number of participants: 228
Treatments
Experimental: BB-031
A single dose of BB-031 will be administered via IV bolus injection
Placebo_comparator: Placebo
A single dose of matching placebo will be administered via IV bolus injection
Related Therapeutic Areas
Sponsors
Leads: Basking Biosciences, Inc.