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MW151 to Treat Cognitive Disorders

Recruiting

This Phase I trial will test the safety and efficacy of MW151, an experimental drug designed to treat cognitive disorders, including Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 50 Years All Yes
October 22, 2019
January 2021
40

  • In good health as determined by medical history, physical exam, laboratory examinations, electrocardiogram, and vital signs
  • Weight of more than 50 kg (110 pounds)
  • BMI of less than 34
  • Electrocardiogram without clinically significant abnormalities
  • Systolic blood pressure equal to or less than 150 mmHg; diastolic BP equal to or less than 90 mmHg at screening
  • Adequate venous access for blood draws
  • Women are postmenopausal or agree to use birth control during the study and for 1 month after dosing; men are surgically sterile or agree to use a condom with spermicide if sexually active during the study and for 1 month after dosing

  • Any unstable chronic medical condition requiring interventional treatment that might increase participant's risk or confound observations
  • Evidence of active infection requiring antibiotic therapy within 14 days prior to receiving study drug
  • Medical history of vasculitis or any autoimmune disease, excluding seasonal allergic rhinitis and childhood history of atopic dermatitis
  • Treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin
  • Human immunodeficiency virus (HIV) 
  • History of acute/chronic hepatitis B or C and/or carrier of hepatitis B
  • Clinically significant abnormalities in screening laboratory tests
  • Prohibited medications: over-the-counter and herbal medications within 10 days prior to study dosing (with exception of calcium/vitamin D supplements and ocular medications); nonsteroidal anti-inflammatory drugs or immunosuppressive drugs within 10 days prior to dosing; use of known CYP450 CYP1A2, CYP2D6 or CYP3A4 inhibitors or inducers within 14 days of dosing or planned use during the study; investigational drug, vaccine, device, or blood product within 3 months prior to study
  • Any disorder that could interfere with the study drug (e.g., small bowel disease, Crohn's disease, celiac disease, or liver disease)
  • Current or past psychosis, bipolar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years; suicidal ideation
  • History of substance abuse within the past 5 years
  • Smoker
  • History of serious head injury
  • Chronic kidney disease
  • Pregnant or nursing

Participants will be randomly assigned to take one of five doses of the study drug or a placebo while hospitalized for 4 days. They will take the drug once and have a follow-up visit 4 days after discharge. MW151 acts on brain cells called microglia to block the overproduction of cytokines, reducing inflammation in the brain. The study's primary aim is to evaluate the drug's safety and activity in the human body.

Name City State Zip Status Primary Contact
Duke Clinical Research Institute
Durham North Carolina 27705 Recruiting Jeffrey T Guptill, MD
919-668-8445
Jeffrey.guptill@duke.edu

Linda Van Eldik

  • Duke Clinical Research Institute
  • National Institute on Aging (NIA)
  • ImmunoChem Therapeutics, LLC

Name Role Affiliation
Linda J Van Eldik, PhD Principal Investigator University of Kentucky

Name Phone Email
Linda J Van Eldik, PhD 859-257-5566 linda.vaneldik@gmail.com

NCT04120233

A Phase 1a, Double-Blind, Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of MW151 Administered Orally to Healthy Volunteers