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RecruitingPhase 2

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

Basking Biosciences, Inc. · NCT06226805

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
228
US sites recruiting
10
Study start
July 31, 2024
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: BB-031; Placebo

Conditions: Acute Ischemic Stroke

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 CTA or MRA
  • Known severe renal disease
  • Known hypersensitivity to any constituent of BB-031

Recruiting US locations

  • HonorHealth Bob Bove Neuroscience Institute

    Scottsdale, AZ 85251

    Site contact: Study Coordinator

  • Pacific Neurosciences Institute at Saint John's Physician Partners

    Torrance, CA 90503

    Site contact: Study Coordinator

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Study Coordinator

  • Washington University in St. Louis

    St Louis, MO 63110

    Site contact: Study Coordinator

  • Cooper University Hospital

    Camden, NJ 08103

    Site contact: Study Coordinator

  • WakeMed

    Raleigh, NC 27610

    Site contact: Study Coordinator

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Study Coordinator

  • ProMedica Toledo Hospital

    Toledo, OH 43604

    Site contact: Study Coordinator

  • Mercy Health St. Vincent Medical Center

    Toledo, OH 43608

    Site contact: Study Coordinator

  • Valley Baptist Medical Center - Harlingen

    Harlingen, TX 78550

    Site contact: Study Coordinator

Study contacts (from the official record)

  • Program Director · 9196184721 · snelson@baskingbiosciences.com
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Study of BB-031 in Acute Ischemic Stroke Patients (RAISE) (NCT06226805) | Bored Studies