Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
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
Basking Biosciences, Inc.
228 participants
Jul 31, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria8
- 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
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Interventions
Solution for injection
0.9% sodium chloride for injection
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT06226805