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.
Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 45 years of age, with body mass index (BMI) > 18.0 and < 30.0 kg/m2 , and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
the absence of clinically significant illness and surgery within 4 weeks prior to the first dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator.
the absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
post-menopausal female (absence of menses for 12 months prior to the first study drug administration, or having had a bilateral oophorectomy, or hysterectomy with bilateral oophorectomy at least 6 months prior to the first study drug administration); or
Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
Subjects with any following clinical illness at screening, including but not limited to respiratory, circulatory, digestive, hematological, endocrine, immunological, dermatological, and ENT abnormalities.
Subjects with digestive, liver, or kidney diseases which could affect the pharmacokinetics of drugs.
Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
Parallel
MN-08 24 mg/day
DrugSubjects 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.
MN-08 60 mg/day
DrugSubjects 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.
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.
Single dose peak plasma concentration (Cmax) for MN-08
Peak plasma concentration (Cmax) for MN-08 after single oral doses of MN-08 tablets.
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.
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.
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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