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

NCT06226805 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BB-031-CLIN-201
• Study Type: interventional
• Target: 228
• Locations: 3 countries
• Sites: 24

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Wake-up stroke; Large vessel occlusion; Intracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

• Symptomatic Intracranial Hemorrhage (sICH)

  Proportion of participants having a sICH

  24 hours

Secondary Outcomes (2)

• Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)

  24 hours

• Adverse Events (AEs)

  24 hours

Other Outcomes (13)

• Mortality

  30 days, 90 days

• Pharmacokinetic (PK) Plasma Level Assessment

  48 hours

• Pharmacokinetic (PK) Parameter

  48 hours

Study Arms (2)

BB-031

EXPERIMENTAL

A single dose of BB-031 will be administered via IV bolus injection

Drug: BB-031

Placebo

PLACEBO COMPARATOR

A single dose of matching placebo will be administered via IV bolus injection

Drug: Placebo

Interventions

BB-031 DRUG

Solution for injection

Also known as: DTRI-031

BB-031

Placebo DRUG

0.9% sodium chloride for injection

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute ischemic stroke
• years or older
• Anterior circulation intra-cranial occlusion
• NIHSS score \>3
• Onset of stroke symptoms within 24 hours of enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Basking Biosciences, Inc.: lead

Study Sites (24)

HonorHealth Bob Bove Neuroscience Institute

Scottsdale, Arizona, 85251, United States

RECRUITING

Mills Peninsula Medical Center

Burlingame, California, 94010, United States

WITHDRAWN

MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States

WITHDRAWN

California Pacific Medical Center

San Francisco, California, 94109, United States

WITHDRAWN

Pacific Neurosciences Institute at Saint John's Physician Partners

Torrance, California, 90503, United States

RECRUITING

Baptist Health Medical Center

Jacksonville, Florida, 32207, United States

TERMINATED

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

WakeMed

Raleigh, North Carolina, 27610, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, 43604, United States

RECRUITING

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43608, United States

RECRUITING

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, 78550, United States

RECRUITING

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

University of Calgary

Calgary, Alberta, T2N2T9, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Intracranial Hemorrhages

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael D Hill, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Shahid M Nimjee, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

9196184721; snelson@baskingbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive a single dose of blinded investigational drug or placebo.

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 26, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); AU (6); CA (3)