Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Description

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Conditions

Intracerebral Hemorrhage

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Study Overview

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Study Details

Study overview

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Condition
Intracerebral Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35294

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06511

Stuart

Cleveland Clinic Florida, Stuart, Florida, United States, 34994

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

Brooklyn

New York University Grossman School of Medicine, Brooklyn, New York, United States, 11220

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45219

Houston

University of Texas Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed diagnosis of spontaneous, non-traumatic ICH.
  • * 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)
  • * Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms
  • * Age ≥ 18 years
  • * Able to receive first dose of test article ≤ 24h after onset of ICH symptoms
  • * NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization
  • * Controlled blood pressure (systolic BP \< 180 mm Hg) at randomization.
  • * Premorbid magnetic resonance spectroscopy (mRS) of 0-2
  • * Has adequate venous access
  • * No planned surgical intervention except EVD
  • * Written informed consent from the patient or legally authorized representative (LAR)
  • * Unstable hematoma defined as \> 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms.
  • * Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed).
  • * Uncontrolled temp \>38.5˚C at enrollment.
  • * Signs of intracranial infection or emergence of a systemic infection
  • * Is pregnant or lactating
  • * Signs of liver and kidney chronic disease (i.e. creatinine \>2, bilirubin \> 3, receiving dialysis)
  • * Non-reversible bleeding diathesis
  • * Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days.
  • * Anticipated withdrawal of life-sustaining therapies within the first week after admission.
  • * In the opinion of the investigator, patient has any contraindication to the planned study assessments.
  • * In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.
  • * Concomitant enrollment in another acute interventional study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Linda Van Eldik, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2026-10-01