Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06226805

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

Led by Basking Biosciences, Inc. · Updated on 2026-05-14

228

Participants Needed

25

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of acute ischemic stroke
  • Age 18 years or older
  • Confirmed anterior circulation intra-cranial occlusion
  • NIH Stroke Scale score greater than 3
  • Stroke symptoms began within 24 hours of enrollment
Not Eligible

You will not qualify if you...

  • Large volume ischemic stroke
  • Presence of intracranial hemorrhage on baseline or prior imaging
  • Chronic intracranial occlusion
  • Body weight greater than 125 kg
  • Previous treatment with thrombolytic drugs or glycoprotein IIb/IIIa inhibitors
  • Active significant bleeding, bleeding disorders, or high risk for bleeding
  • Stroke occurring within the last 90 days
  • Inability to undergo brain perfusion scan with MRI or CT using contrast

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

HonorHealth Bob Bove Neuroscience Institute

Scottsdale, Arizona, United States, 85251

Actively Recruiting

2

Mills Peninsula Medical Center

Burlingame, California, United States, 94010

Withdrawn

3

MemorialCare Long Beach Medical Center

Long Beach, California, United States, 90806

Withdrawn

4

California Pacific Medical Center

San Francisco, California, United States, 94109

Withdrawn

5

Pacific Neurosciences Institute at Saint John's Physician Partners

Torrance, California, United States, 90503

Actively Recruiting

6

Baptist Health Medical Center

Jacksonville, Florida, United States, 32207

Terminated

7

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

8

Washington University in St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

9

Cooper University Hospital

Camden, New Jersey, United States, 08103

Actively Recruiting

10

WakeMed

Raleigh, North Carolina, United States, 27610

Actively Recruiting

11

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

12

ProMedica Toledo Hospital

Toledo, Ohio, United States, 43604

Actively Recruiting

13

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States, 43608

Actively Recruiting

14

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, United States, 78550

Actively Recruiting

15

Memorial Hermann Hospital

Houston, Texas, United States, 77030

Actively Recruiting

16

John Hunter Hospital

New Lambton Heights, New South Wales, Australia, 2305

Actively Recruiting

17

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

18

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Actively Recruiting

19

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Actively Recruiting

20

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

21

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

22

University of Calgary

Calgary, Alberta, Canada, T2N2T9

Actively Recruiting

23

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2G3

Actively Recruiting

24

Vancouver Stroke Program

Vancouver, British Columbia, Canada, V5Z1M9

Actively Recruiting

25

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1Y 4E9

Actively Recruiting

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Research Team

P

Program Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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