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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Tablet
Frontage Clinical Services, 1nc.
Secaucus, New Jersey, United States
Incidence of Dose Limiting Toxicities (DLTs)
Any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as \> Grade 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0), where applicable, deemed by the investigator as at least "possibly, probably or definitely related" to the drug but unrelated to concurrent illness, or concomitant medications.
Time frame: Day 1 through 7 days after the last study drug administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An adverse event may or may not be related to the study treatment.
Time frame: Day 1 through 7 days after the last study drug administration
Incidence of withdrawals due to Adverse Events (AEs)
Incidence of withdrawals due to Adverse Events (AEs) defined above
Time frame: Day 1 through 7 days after the last study drug administration
Change in complete blood count test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in comprehensive metabolic panel test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in urinalysis test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in pregnancy test
Time frame: Change from baseline to day 7 after the first study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of pulse
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of pulse
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of temperature
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of temperature
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of respiratory rate
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of respiratory rate
Time frame: Change from pre-dose to day 7 after the last study drug administration
ECG ventricular rate (beats per minute)
Time frame: At pre-dose
ECG ventricular rate (beats per minute)
Time frame: 96 hours after study drug administration
ECG ventricular rate (beats per minute)
Time frame: On day 7 after the last study drug administration
PR interval (msec)
Time frame: At pre-dose
PR interval (msec)
Time frame: 96 hours after study drug administration
PR interval (msec)
Time frame: On day 7 after the last study drug administration
QRS interval (msec)
Time frame: At pre-dose
QRS interval (msec)
Time frame: 96 hours after study drug administration
QRS interval (msec)
Time frame: On day 7 after the last study drug administration
QT interval (msec)
Time frame: At pre-dose
QT interval (msec)
Time frame: 96 hours after study drug administration
QT interval (msec)
Time frame: On day 7 after the last study drug administration
QTc interval (msec)
Time frame: At pre-dose
QTc interval (msec)
Time frame: 96 hours after study drug administration
QTc interval (msec)
Time frame: On day 7 after the last study drug administration
Maximum observed plasma drug concentration (Cmax)
Time frame: 0-96 hours
Apparent terminal elimination half-life (t1/2)
Time frame: 0-96 hours
Time to maximum observed plasma drug concentration (Tmax)
Time frame: 0-96 hours
Area under the plasma drug concentration-time curve (AUC)
Time frame: 0-96 hours
Percentage of AUC0-∞ extrapolated from Tlast to infinity (AUCext)
Time frame: 0-96 hours
Apparent plasma clearance (CL/F)
Time frame: 0-96 hours
Apparent Volume of distribution (Vz/F)
Time frame: 0-96 hours
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