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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
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-31
Primary completion: 2026-12-01
Study completion finish: 2027-03-01
Study type
PREVENTION
Phase
PHASE2
Trial ID
NCT06226805
Intervention or treatment
DRUG: BB-031
DRUG: Placebo
Conditions
- • Acute Ischemic Stroke
Find a site
Closest Location:
The Royal Melbourne Hospital
Research sites nearby
Select from list below to view details:
The Royal Melbourne Hospital
Parkville, Victoria, Australia
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
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Symptomatic Intracranial Hemorrhage (sICH) | Proportion of participants having a sICH | 24 hours |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
Frequently Asked Questions
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