A MAD Study of TT301/MW189 in Healthy Volunteers
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a phase 1b study. Written informed consent will be obtained from each study
      participant before any study-specific procedures or assessments are done.

      At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on
      study participants.

      Throughout the study the investigator will be assessing adverse events and concomitant
      medication.

      On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1
      unit after fasting a minimum of 10 hours, for admission into the unit and will undergo
      procedures:

        -  Medical and medication histories

        -  Infection screen

        -  Body temperature

        -  Vital signs (blood pressure and heart rate)

        -  Physical examination and weight

        -  Neurological exam

        -  Safety laboratory tests (blood and urine)

        -  Urine pregnancy test (females only)

        -  Alcohol screening (Breathalyzer)

        -  Urine drug screen

        -  Hepatitis B, C and HIV screening

        -  Randomize: Only participants who meet eligibility requirements will be randomized into
           the study.

      Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the
      following tests/procedures performed at various time points during the day following
      confirmation of eligibility.

        -  8 electrocardiograms (ECG)

        -  8 vital signs (blood pressure and heart rate)

        -  1 body temperature

        -  12 PK Blood draws

        -  2 study drug administrations

      Day 2: A light breakfast will be given prior to dosing.

        -  8 ECGs

        -  8 vital signs (blood pressure and heart rate)

        -  1 body temperature

        -  1 PK blood draw

        -  2 study Drug administration

      Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast
      will be given before dosing

        -  1 safety laboratory tests (blood and urine)

        -  1 ECG

        -  2 vital signs (blood pressure and heart rate)

        -  1 body temperature

        -  1 PK blood draw

        -  1 neurological examination

        -  2 study drug administrations

      Day 4: A Light breakfast will be given before dosing

        -  2 vital signs (blood Pressure and heart rate)

        -  1 body temperature

        -  1 PK blood draw

        -  2 study drug administrations

      Day 5: A Light breakfast will be given before dosing

        -  1 ECG

        -  2 vital signs (Blood Pressure and heart rate)

        -  1 body temperature

        -  12 PK blood draw

        -  2 study drug administration

      Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast
      will be given

        -  1 safety laboratory test (blood and urine)

        -  1 vital sign (Blood pressure and heart rate)

        -  1 body temperature

        -  1 neurological examination

        -  2 PK blood draw

      Day 7: A light breakfast will be provided

        -  1 vital sign

        -  1 body temperature

        -  1 PK blood draw

      Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A
      light breakfast will be offered

        -  1 safety laboratory test (blood and urine)

        -  1 ECG

        -  1 vital sign (blood pressure and heart rate)

        -  1 body temperature

        -  1 physical examination including weight

        -  1 neurological examination

           2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is
           allowed.

      during this visit participants will have the following tests and procedures performed:

        -  1 safety laboratory test (blood and urine)

        -  1 ECG

        -  1 vital sign (blood pressure and heart rate)

        -  1 body temperature

      6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any
      medications they may be taking.
    

Intervention name(s): 0.075mg/kg TT301/MW189; 0.15mg/kg TT301MW189; 0.25mg/kg TT301/MW189; 0.30mg/kg TT301/MW189; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): TT301/MW189; TT301/MW189; TT301/MW189; TT301/MW189
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment