A MAD Study of TT301/MW189 in Healthy Volunteers
Condition: Healthy Adult Volunteers
Intervention: 0.075mg/kg TT301/MW189; 0.15mg/kg TT301MW189; 0.25mg/kg TT301/MW189; 0.30mg/kg TT301/MW189; Placebo
Intervention description: 0.075 mg/kg IV twice daily on Days 1 through 5; 0.15 mg/kg IV twice daily on Days 1 through 5; 0.25 mg/kg IV twice daily on Days 1 through 5; 0.30 mg/kg IV twice daily on Days 1 through 5; 0.9% sodium chloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this Study is to find out whether an investigational drug is safe and well
      tolerated. MW189 is being studied as a possible short-term treatment for people with
      different types of brain injury. MW189 has previously been given to healthy human volunteers
      as a single dose, and there were no significant problems or bad effects in people who
      received the Study drug. However, before it can be tested in people with brain injury, it is
      important to test MW189 in healthy volunteers when given multiple doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness and capacity to give informed consent

          -  Is in good health

          -  Weights 50.0 - 120.0 kg

          -  Not pregnant

          -  Must agree to use birth control for 1 week after the last day of study drug
             administration

          -  Willingness to comply with protocol requirements, including fasting, alcohol and
             nicotine restrictions, during the study and is available to complete the study

          -  Adequate forearm vein access

          -  No significant dietary restrictions

          -  Must not have donated blood, platelets, or any other blood components 30 days, or
             plasma 60 days, prior to consenting. Must also agree not to donate blood, platelets,
             or any other blood components for 8 weeks after the last dose of study drug

        Exclusion Criteria:

          -  Lactating or is pregnant

          -  severe ischemic heart disease or congestive heart failure

          -  Heart attack within the previous 2 years;

          -  history of stroke or cardiomyopathy;

          -  significant liver or kidney disease;

          -  diabetes;

          -  history of any autoimmune disorder; or a history of chronic infections

          -  a history of cancer

          -  has received antibiotic treatment or has undergone a surgical procedure within 30 days
             of Day 1

          -  has a history of Hepatitis C, Hepatitis B or tuberculosis (TB)

          -  has a history of Human Immunodeficiency Virus (HIV)

          -  a history of alcohol or drug use within the twelve months prior to study drug
             administration

          -  has used any immunosuppressants or chronic anti-inflammatory drugs medication
             including prescription medication, over-the-counter medication, health/herbal
             supplement or vitamin by any route of administration within 7 days of Day 1

          -  has donated blood within 30 days of consenting or has donated plasma within 60 days of
             consenting

          -  has participated in a clinical trial of an immunosuppressive drug within 6 months of
             Day 1

          -  has received an investigational drug, used an investigational device or received an
             investigational medical procedure within 60 days of Day 1, or concurrent with
             participation in this study

          -  has participated in any observational studies, experimental studies of
             non-investigational drugs, devices, or medical procedures within 30 days of Day 1, or
             concurrent with participation in this study

          -  has participated in a previous trial with TT301/MW189

          -  has a history of unexplained syncope or fainting from the collection of blood; i.e.,
             autonomic dysfunction.

          -  Lack of ability to understand verbal and/ or written English

          -  had significant trauma or surgical procedure within 1 month prior to Screening.