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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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)
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)
University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Difference in the proportion of all cause-morality between arms
Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.
Time frame: 7 days post-randomization
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Cleveland Clinic Florida
Stuart, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York University Grossman School of Medicine
Brooklyn, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Texas Houston
Houston, Texas, United States
...and 1 more locations