This trial is a single-center, Phase 1, placebo-controlled, double-blind, multiple-dose study in two ascending dose cohorts of healthy subjects. The primary objective of the trial is to assess the safety and tolerability of multiple doses of MN-08 tablet administered for 6.5 consecutive days in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Subjects in this cohort will receive 12 mg MN-08 tablets b.i.d. for a total daily dose of 24 mg or matching placebo for 6 consecutive days, and the last dose (12 mg) on the morning of Day 7.
Subjects in this cohort will receive 30 mg MN-08 tablets b.i.d. for a total daily dose of 60 mg or matching placebo tablets for 6 consecutive days, and the last dose (30 mg) on the morning of Day 7.
Incidence and severity of TEAEs and SAEs
Incidence and severity of treatment emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) after multiple doses of MN-08 administered for 6.5 consecutive days in healthy subjects.
Time frame: Through study completion, an average of 12 days
Incidence and severity of treatment-related adverse events
Incidence and severity of treatment-related adverse events determined by changes from screening (baseline) of findings from vital signs, ECG, and clinical laboratory parameters per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: Through study completion, an average of 12 days
Single dose peak plasma concentration (Cmax) for MN-08
Peak plasma concentration (Cmax) for MN-08 after single oral doses of MN-08 tablets.
Time frame: Pre dose and up to 12 hours post dose after the morning dosing of Day 1.
Single dose area under the plasma concentration versus time curve (AUC) for MN-08
Area under the plasma concentration versus time curve (AUC) for MN-08 after single oral doses of MN-08 tablets.
Time frame: Pre dose and up to 12 hours post dose after the morning dosing of Day 1.
Single dose time to peak plasma concentration (Tmax) for MN-08
Time to peak plasma concentration (Tmax) for MN-08 after single oral doses of MN-08 tablets.
Time frame: Pre dose and up to 12 hours post dose after the morning dosing of Day 1.
Repeated dose peak plasma concentration (Cmax) for MN-08
Peak plasma concentration (Cmax) for MN-08 after multiple oral doses of MN-08 tablets.
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Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.
Repeated dose steady-state plasma concentration (Css) for MN-08
Steady-state concentration (Css) for MN-08 after multiple oral doses of MN-08 tablets.
Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.
Repeated dose area under the plasma concentration versus time curve (AUC) for MN-08
Area under the plasma concentration versus time curve (AUC) for MN-08 after multiple oral doses of MN-08 tablets.
Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.
Repeated dose time to peak plasma concentration (Tmax) for MN-08
Time to peak plasma concentration (Tmax) for MN-08 after multiple oral doses of MN-08 tablets.
Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.
Repeated dose terminal elimination half-life (t1/2) for MN-08 in plasma
Terminal elimination half-life (t1/2) for MN-08 after multiple oral doses of MN-08 tablets.
Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.
Repeated dose ratio of accumulation (RA) for MN-08
Ratio of accumulation (RA) for MN-08 after multiple oral doses of MN-08 tablets.
Time frame: Pre dose and up to 120 hours post dose after the morning dosing of Day 7.