Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

• Status: Not yet recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA); University of Kentucky

Criteria

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