Acute Ischemic Stroke
Conditions
Keywords
Stroke, Wake-up stroke, Large vessel occlusion, Intracranial hemorrhage
Brief 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.
Detailed description
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.
Interventions
DRUGBB-031
Solution for injection
DRUGPlacebo
0.9% sodium chloride for injection
Sponsors
Basking Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will receive a single dose of blinded investigational drug or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Intracranial Hemorrhage (sICH) | 24 hours | Proportion of participants having a sICH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic intracranial hemorrhage (non-symptomatic-ICH) | 24 hours | Proportion of participants having a non-symptomatic-ICH |
| Adverse Events (AEs) | 24 hours | Incidence and severity of treatment-emergent AEs |
Countries
Australia, Canada, United States
Contacts
CONTACTProgram Director
PRINCIPAL_INVESTIGATORMichael D Hill, MD
University of Calgary
PRINCIPAL_INVESTIGATORShahid M Nimjee, MD, PhD
Ohio State University
Outcome results
None listed