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

Description

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 156 patients are planned in this study.

Conditions

Acute Ischemic Stroke

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Study Overview

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Study Details

Study overview

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 156 patients are planned in this study.

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

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

Condition
Acute Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Burlingame

Mills Peninsula Medical Center, Burlingame, California, United States, 94010

Long Beach

MemorialCare Long Beach Medical Center, Long Beach, California, United States, 90806

San Francisco

California Pacific Medical Center, San Francisco, California, United States, 94109

Jacksonville

Baptist Health Medical Center, Jacksonville, Florida, United States, 32207

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Toledo

ProMedica Toledo Hospital, Toledo, Ohio, United States, 43604

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinical diagnosis of acute ischemic stroke
  • * 18 years or older
  • * Anterior circulation intra-cranial occlusion
  • * Onset of stroke symptoms within 24 hours of enrollment
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Basking Biosciences, Inc.,

Michael D Hill, MD, PRINCIPAL_INVESTIGATOR, University of Calgary

Shahid M Nimjee, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

2027-03