Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
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.
Study details:
This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, approximately 36 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 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- PHASE2
Study ID
NCT06226805
Intervention or treatment
DRUG: BB-031
DRUG: Placebo
Conditions
- Acute Ischemic Stroke
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
John Hunter Hospital
Select from list below to view details:
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
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Who is running the clinical trial?
Basking Biosciences, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: BB-031
| Drug: BB-031 |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Intracranial Hemorrhage (sICH) | Proportion of participants having a sICH | 24 hours |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic intracranial hemorrhage (non-symptomatic-ICH) | Proportion of participants having a non-symptomatic-ICH | 24 hours |
| Adverse Events (AEs) | Incidence and severity of treatment-emergent AEs | 24 hours |
References
Clinical Trials Gov: Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)Other trials to consider
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