Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Purpose

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).

Condition

  • Intracerebral Hemorrhage

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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)

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel 1:1
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, study staff, analytic staff (to patient identifiers), sponsor staff (only to treatment allocation, unblinded to enable handling and review of data and drug accountability prior to database lock)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental 		MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
  • Drug: MW189
    MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
Placebo Comparator
Control 		Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
  • Other: Saline
    Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Kevin Hatton, MD
859-218-0115
kevin.hatton@uky.edu

More Details

NCT ID
NCT05020535
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Daniel Hanley
(410) 361-7999
dhanley@jhmi.edu

Detailed 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). This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms. MW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.