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

Acute Ischemic Stroke

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion 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

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 Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Study Coordinator

Study Sponsored By
Basking Biosciences, Inc.
Participants Required
More Information
Study ID: NCT06226805