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New stroke drug BB-031 enters human testing

NCT ID NCT06226805

Disease control Sponsor: Basking Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called BB-031 in people who have had a stroke within the last 24 hours. About 228 participants will receive either the drug or a placebo, and researchers will check for safety, side effects, and how the drug works in the body over 90 days. The main goal is to see if the drug causes bleeding in the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BB-031 (also called DTRI-031), a drug given as an injection
What this could lead to
If it works, this could point toward a new treatment to improve outcomes after a stroke by reducing damage.
What could go wrong
This is an early Phase 2 trial with only 228 participants, so results may not apply to everyone. The drug could cause bleeding in the brain or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Intracranial Hemorrhages ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Health Medical Center

    TERMINATED

    Jacksonville, Florida, 32207, United States

  • California Pacific Medical Center

    WITHDRAWN

    San Francisco, California, 94109, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • HonorHealth Bob Bove Neuroscience Institute

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • John Hunter Hospital

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • MemorialCare Long Beach Medical Center

    WITHDRAWN

    Long Beach, California, 90806, United States

  • Mercy Health St. Vincent Medical Center

    RECRUITING

    Toledo, Ohio, 43608, United States

  • Mills Peninsula Medical Center

    WITHDRAWN

    Burlingame, California, 94010, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4E9, Canada

  • Pacific Neurosciences Institute at Saint John's Physician Partners

    RECRUITING

    Torrance, California, 90503, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43604, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N2T9, Canada

  • Valley Baptist Medical Center - Harlingen

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Vancouver Stroke Program

    RECRUITING

    Vancouver, British Columbia, V5Z1M9, Canada

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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