NCT06226805 · Basking Biosciences, Inc.
Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
(RAISE)
What this study is about
The purpose of this study is to evaluate the safety and how well patients handle the treatment 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 randomly assigned to receive one dose of either the experimental drug or placebo and will be followed for 90 days.
View original scientific 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. 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 156 patients are planned in this study.
Interventions
DRUG
BB-031
Solution for injection
DRUG
Placebo
0.9% sodium chloride for injection
Primary outcome measures
Symptomatic Intracranial Hemorrhage (sICH)
Time frame: 24 hours
Proportion of participants having a sICH
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Clinical diagnosis of acute ischemic stroke
- 18 years or older
- Anterior circulation intra-cranial occlusion
- 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
- Scottsdale, Arizona
- Burlingame, California
- Long Beach, California
- San Francisco, California
- Torrance, California
- Jacksonville, Florida
- Detroit, Michigan
- St Louis, Missouri
- Camden, New Jersey
- Raleigh, North Carolina
- Columbus, Ohio
- Toledo, Ohio
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations