A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary study objective is to establish the safety and tolerability of MT101-5 after a
      single and multiple dose administrations in healthy volunteers. The safety and overall
      tolerability of MT101-5 will be evaluated based on:

        -  Incidence of Dose Limiting Toxicities (DLTs)

        -  Incidence of Treatment-Emergent Adverse Events (TEAEs).

        -  Incidence of withdrawals due to Adverse Events (AEs).

        -  Change/shifts in laboratory values. Change in vital signs.

        -  Change in Electrocardiogram (ECG) parameters.

        -  Changes in physical examination findings
    

Detailed description: 
      SAD Phase including Food Interaction:

      Subjects will be assigned to one of up to five MT101-5 treatment cohorts and will be randomly
      assigned 6:2 within their cohort to receive MT101-5 or placebo. On Day 1, following an
      overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be
      administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water.
      Additional water is permitted ad lib except for the period 1 hour before to 1 hour after
      administration of the drug product. No food is allowed for at least 4 hours after the dose.
      Subjects should receive standardized meals scheduled at the same time throughout the study.

      For the Food Interaction phase, on Day 1 following an overnight fast of at least 10 hours,
      the study subjects should start their standardized high-fat breakfast meal 30 minutes before
      administration of the drug product. Trial subjects should eat this meal in 30 minutes or
      less. Subjects will be administered MT101-5 or placebo as an oral tablet 30 minutes after
      start of intake of a standardized high-fat breakfast with 240 mL (8 fluid ounces) of water.
      Additional water is allowed ad lib except for 1 hour before and 1 hour after drug
      administration. No food is allowed for at least 4 hours after the dose.

      MAD Phase:

      Subjects will be randomly assigned 6:2 to receive MT101-5 or placebo once daily for 7 days.
      On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of
      MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e.,
      8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour
      before to 1 hour after administration of the drug product. No food is allowed for at least 4
      hours after the dose. Subjects should receive standardized meals scheduled at the same time
      throughout the study. The same will be followed for days 2-7.
    

Intervention name(s): MT101-5
Intervention type(s): Drug
Intervention description(s): Tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment