Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

NCT06226805 · tracked via the Priya Life Science USA tracker

Sponsor

Basking Biosciences, Inc.

Phase

Phase 2

Started

2024-07-31

Last updated

2026-05-14

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

BB-031Placebo

BB-031: Solution for injection

Placebo: 0.9% sodium chloride for injection

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Symptomatic Intracranial Hemorrhage (sICH) — 24 hours
Proportion of participants having a sICH

Trial sites (25)

Facility	City	Region	Status
HonorHealth Bob Bove Neuroscience Institute	Scottsdale	Arizona	Recruiting
Mills Peninsula Medical Center	Burlingame	California	Withdrawn
MemorialCare Long Beach Medical Center	Long Beach	California	Withdrawn
California Pacific Medical Center	San Francisco	California	Withdrawn
Pacific Neurosciences Institute at Saint John's Physician Partners	Torrance	California	Recruiting
Baptist Health Medical Center	Jacksonville	Florida	Terminated
Henry Ford Hospital	Detroit	Michigan	Recruiting
Washington University in St. Louis	St Louis	Missouri	Recruiting
Cooper University Hospital	Camden	New Jersey	Recruiting
WakeMed	Raleigh	North Carolina	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
ProMedica Toledo Hospital	Toledo	Ohio	Recruiting
Mercy Health St. Vincent Medical Center	Toledo	Ohio	Recruiting
Valley Baptist Medical Center - Harlingen	Harlingen	Texas	Recruiting
Memorial Hermann Hospital	Houston	Texas	Recruiting
John Hunter Hospital	New Lambton Heights	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting
Royal Adelaide Hospital	Adelaide	South Australia	Recruiting
Monash Medical Centre	Clayton	Victoria	Recruiting
The Royal Melbourne Hospital	Parkville	Victoria	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
University of Calgary	Calgary	Alberta	Recruiting
University of Alberta Hospital	Edmonton	Alberta	Recruiting
Vancouver Stroke Program	Vancouver	British Columbia	Recruiting
Ottawa Hospital Research Institute	Ottawa	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06226805 on ClinicalTrials.gov ↗ ← All trials in the USA