Recruiting
Phase 2

BB-031

Sponsor:

Basking Biosciences, Inc.

Code:

NCT06226805

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BB-031

Placebo

Study Details

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.

Conditions

Acute Ischemic Stroke

Study ID

NCT06226805

Start date

Jul 31, 2024

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

BB-031

Solution for injection

Placebo

0.9% sodium chloride for injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Program Director

9196184721snelson@baskingbiosciences.com

Locations

HonorHealth Bob Bove Neuroscience Institute

Recruiting

Scottsdale, Arizona, United States, 85251

Pacific Neurosciences Institute at Saint John's Physician Partners

Recruiting

Torrance, California, United States, 90503

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43604

Mercy Health St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608

Valley Baptist Medical Center - Harlingen

Recruiting

Harlingen, Texas, United States, 78550

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N2T9

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Vancouver Stroke Program

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

More Information

Sponsor

Basking Biosciences, Inc.

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Stroke
  • Wake-up stroke
  • Large vessel occlusion
  • Intracranial hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Basking Biosciences, Inc. on 2026-05-14.