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

NCT ID: NCT06226805

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Keywords

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Stroke Wake-up stroke Large vessel occlusion Intracranial hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will receive a single dose of blinded investigational drug or placebo.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BB-031

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

Group Type EXPERIMENTAL

BB-031

Intervention Type DRUG

Solution for injection

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% sodium chloride for injection

Interventions

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BB-031

Solution for injection

Intervention Type DRUG

Placebo

0.9% sodium chloride for injection

Intervention Type DRUG

Other Intervention Names

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DTRI-031 Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basking Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Hill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Shahid M Nimjee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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HonorHealth Bob Bove Neuroscience Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

Mills Peninsula Medical Center

Burlingame, California, United States

Site Status WITHDRAWN

MemorialCare Long Beach Medical Center

Long Beach, California, United States

Site Status WITHDRAWN

California Pacific Medical Center

San Francisco, California, United States

Site Status WITHDRAWN

Providence Little Company of Mary Medical Center

Torrance, California, United States

Site Status NOT_YET_RECRUITING

Baptist Health Medical Center

Jacksonville, Florida, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

WakeMed

Raleigh, North Carolina, United States

Site Status RECRUITING

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, United States

Site Status RECRUITING

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, United States

Site Status NOT_YET_RECRUITING

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status RECRUITING

Monash Medical Centre

Clayton, Victoria, Australia

Site Status RECRUITING

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status RECRUITING

University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

Central Contacts

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Program Director

Role: CONTACT

Phone: 9196184721

Email: [email protected]

Facility Contacts

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Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Other Identifiers

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BB-031-CLIN-201

Identifier Type: -

Identifier Source: org_study_id