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

May 13, 2026 updated by: Basking Biosciences, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 180 participants will be randomized to receive a single dose of two sequential dose levels of study drug or placebo.

All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study as outlined in the protocol.

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Hospital
        • Contact:
          • Study Coordinator
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Study Coordinator
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Study Coordinator
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Medical Centre
        • Contact:
          • Study Coordinator
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Contact:
          • Study Coordinator
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Study Coordinator
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • University of Calgary
        • Contact:
          • Study Coordinator
      • Edmonton, Alberta, Canada, T6G 2G3
        • Recruiting
        • University of Alberta Hospital
        • Contact:
          • Study Coordinator
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • Vancouver Stroke Program
        • Contact:
          • Research Coordinator
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
          • Study Coordinator
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • HonorHealth Bob Bové Neuroscience Institute
        • Contact:
          • Study Coordinator
    • California
      • Burlingame, California, United States, 94010
        • Withdrawn
        • Mills Peninsula Medical Center
      • Long Beach, California, United States, 90806
        • Withdrawn
        • MemorialCare Long Beach Medical Center
      • San Francisco, California, United States, 94109
        • Withdrawn
        • California Pacific Medical Center
      • Torrance, California, United States, 90503
        • Recruiting
        • Pacific Neurosciences Institute at Saint John's Physician Partners
        • Contact:
          • Study Coordinator
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Terminated
        • Baptist Health Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Study Coordinator
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Contact:
          • Study Coordinator
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
          • Study Coordinator
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed
        • Contact:
          • Study Coordinator
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
          • Study Coordinator
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health St. Vincent Medical Center
        • Contact:
          • Study Coordinator
      • Toledo, Ohio, United States, 43604
        • Recruiting
        • ProMedica Toledo Hospital
        • Contact:
          • Study Coordinator
    • Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Valley Baptist Medical Center - Harlingen
        • Contact:
          • Study Coordinator
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BB-031
A single dose of BB-031 will be administered via IV bolus injection
Drug: BB-031
Solution for injection
Other Names:
  • DTRI-031
Placebo Comparator: Placebo
A single dose of matching placebo will be administered via IV bolus injection
Drug: Placebo
0.9% sodium chloride for injection
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic Intracranial Hemorrhage (sICH)
Time Frame: 24 hours
Proportion of participants having a sICH
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)
Time Frame: 24 hours
Proportion of participants having a non-symptomatic-ICH
24 hours
Adverse Events (AEs)
Time Frame: 24 hours
Incidence and severity of treatment-emergent AEs
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days, 90 days
All-cause mortality
30 days, 90 days
Pharmacodynamic (PD) Assessment
Time Frame: 72 hours
Level of free circulating von Willibrand Factor
72 hours
Pharmacodynamic (PD) Assessment
Time Frame: 72 hours
von Willibrand Factor activity
72 hours
Endovascular Thrombectomy (EVT)
Time Frame: 6 hours
Proportion of participants where EVT was not performed due to clinical improvement or evidence of recanalization
6 hours
Stroke lesion volume
Time Frame: 24 hours
Assessed by MRI or CT
24 hours
ICU length of stay
Time Frame: Up to Day 90
Duration of ICU stay
Up to Day 90
Hospitalization length of stay
Time Frame: Up to Day 90
Duration of hospitalization
Up to Day 90
Successful reperfusion after first pass EVT
Time Frame: 6 hours
Proportion of subjects with successful reperfusion after first pass EVT
6 hours
Pharmacokinetic (PK) Plasma Level Assessment
Time Frame: 48 hours
Plasma levels of study drug
48 hours
Pharmacokinetic (PK) Parameter
Time Frame: 48 hours
Cmax
48 hours
Modified Rankin Scale (mRS) Score
Time Frame: Day 90
Change from baseline score, where 0=no symptoms and 6=dead
Day 90
Recanalization
Time Frame: 2-9 hours
Proportion of participants with recanalization
2-9 hours
National Institutes of Health Stroke Scale (NIHSS) Score
Time Frame: 24 hours, 48 hours, hospital discharge and Day 90
Change from baseline score (total score 0 to 42, with 0 representing no abnormality
24 hours, 48 hours, hospital discharge and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basking Biosciences, Inc.

Investigators

  • Principal Investigator: Michael D Hill, MD, University of Calgary
  • Principal Investigator: Shahid M Nimjee, MD, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-031-CLIN-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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