Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Basking Biosciences, Inc.
Study ID
NCT06226805
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BB-031 — DRUG
    Solution for injection
  • Placebo — DRUG
    0.9% sodium chloride for injection

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: BB-031
    A single dose of BB-031 will be administered via IV bolus injection
  • Placebo Comparator: Placebo
    A single dose of matching placebo will be administered via IV bolus injection

Primary Outcome Measure

Symptomatic Intracranial Hemorrhage (sICH) [ Time Frame: 24 hours ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
HonorHealth Bob Bove Neuroscience InstituteScottsdaleArizona85251
Study Coordinator
Mills Peninsula Medical CenterBurlingameCalifornia94010-
MemorialCare Long Beach Medical CenterLong BeachCalifornia90806-
California Pacific Medical CenterSan FranciscoCalifornia94109-
Pacific Neurosciences Institute at Saint John's Physician PartnersTorranceCalifornia90503
Study Coordinator
Baptist Health Medical CenterJacksonvilleFlorida32207-
Henry Ford HospitalDetroitMichigan48202
Study Coordinator
Washington University in St. LouisSt LouisMissouri63110
Study Coordinator
Cooper University HospitalCamdenNew Jersey08103
Study Coordinator
WakeMedRaleighNorth Carolina27610
Study Coordinator
The Ohio State UniversityColumbusOhio43210
Study Coordinator
Mercy Health St. Vincent Medical CenterToledoOhio43608
Study Coordinator
ProMedica Toledo HospitalToledoOhio43604
Study Coordinator
Valley Baptist Medical Center - HarlingenHarlingenTexas78550
Study Coordinator
Memorial Hermann HospitalHoustonTexas77030
Study Coordinator

Find similar trials in Scottsdale, AZ

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
HonorHealth Bob Bove Neuroscience Institute· Scottsdale, AZMills Peninsula Medical Center· Burlingame, CAMemorialCare Long Beach Medical Center· Long Beach, CACalifornia Pacific Medical Center· San Francisco, CAPacific Neurosciences Institute at Saint John's Physician Partners· Torrance, CABaptist Health Medical Center· Jacksonville, FL

Related Studies