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BB-031 for Stroke (RAISE Trial)

Phase 2
Recruiting
Led By Shahid M Nimjee, MD, PhD
Research Sponsored by Basking Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Onset of stroke symptoms within 24 hours of enrollment
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 90 days

Summary

This trial aims to test the safety and tolerance of increasing doses of BB-031 in acute ischemic stroke patients who arrive at the hospital within 24 hours of their stroke. Participants will be randomly assigned

Who is the study for?
This trial is for adults who've had a stroke within the last 24 hours, caused by a blockage in the arteries that supply blood to the front part of their brain. They must be diagnosed with an acute ischemic stroke.
What is being tested?
The study tests BB-031, a new drug, against a placebo (a substance with no active drug). Participants are randomly chosen to receive either BB-031 or placebo once and will be monitored for three months.
What are the potential side effects?
While specific side effects of BB-031 aren't listed here, common side effects from drugs treating strokes might include bleeding risks, allergic reactions, headache, nausea, or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started having stroke symptoms less than 24 hours ago.
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I am 18 years old or older.
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I have a blockage in the arteries in the front part of my brain.
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I have been diagnosed with a stroke caused by a blood clot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptomatic Intracranial Hemorrhage (sICH)
Secondary study objectives
Adverse Events (AEs)
Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)
Other study objectives
Endovascular Thrombectomy (EVT)
Hospitalization length of stay
ICU length of stay
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BB-031Experimental Treatment1 Intervention
A single dose of BB-031 will be administered via IV bolus injection
Group II: PlaceboPlacebo Group1 Intervention
A single dose of matching placebo will be administered via IV bolus injection

Find a Location

Who is running the clinical trial?

Basking Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
46 Total Patients Enrolled
Shahid M Nimjee, MD, PhDPrincipal InvestigatorOhio State University
Michael D Hill, MDPrincipal InvestigatorUniversity of Calgary
7 Previous Clinical Trials
22,864 Total Patients Enrolled
5 Trials studying Stroke
22,716 Patients Enrolled for Stroke
~104 spots leftby Dec 2026
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