| Eligibility |
Inclusion Criteria:
Subjects must meet all the following criteria to be included in the study:
1. 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.
2. Healthy as defined by:
1. 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.
2. the absence of a clinically significant history of neurological, endocrine,
cardiovascular, respiratory, hematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease.
3. Female subjects must not be pregnant, breastfeeding, or at risk to become pregnant
during study participation. Female subjects must have a negative serum pregnancy test
at screening (within 72 hours of the first dose of study medication) if of
childbearing potential, or be of non-childbearing potential. Non-childbearing
potential is defined as:
1. 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
2. surgically sterile female (hysterectomy or tubal ligation at least 6 months prior
to drug administration).
4. Female subjects of childbearing potential (childbearing potential defined as not post
menopausal nor surgically sterile) must agree to use a reliable method of birth
control (see below for details) or remain abstinent during the study, starting with
the screening visit until at least 90 days after the last study drug administration.
5. Male subjects who have not been vasectomized for at least 6 months, and who are
sexually active with a female partner of childbearing potential must be willing to use
one of the following acceptable contraceptive methods from the first study drug
administration until at least 90 days after the last study drug administration:
1. simultaneous use of a male condom and, for the female partner, hormonal
contraceptives used since at least 4 weeks prior or intra-uterine contraceptive
device placed since at least 4 weeks prior to study.
2. simultaneous use of a male condom and, for the female partner, a diaphragm or
cervical cap with intravaginally applied spermicide.
6. Male subjects (including men who have had a vasectomy) with a pregnant partner must
agree to use a condom from the first study drug administration until at least 90 days
after the last study drug administration.
7. Male subjects must be willing not to donate sperm until 90 days following the last
study drug administration
8. Capable of signing the informed consent form.
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
1. 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.
2. Subjects with any following clinical illness at screening, including but not limited
to respiratory, circulatory, digestive, hematological, endocrine, immunological,
dermatological, and ENT abnormalities.
3. Subjects with digestive, liver, or kidney diseases which could affect the
pharmacokinetics of drugs.
4. Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
5. History of allergic reactions to MN-08 or other related drugs, or to any excipient in
the formulation.
6. Positive pregnancy test at screening.
7. Clinically significant ECG abnormalities or vital sign abnormalities, including:
systolic BP lower than 90 or over 139 mmHg, diastolic BP lower than 60 or over 89
mmHg, or HR less than 55 or over 100 bpm; orthostatic BP: decrease in systolic blood
pressure of 20 mmHg or higher, decrease in diastolic blood pressure of 10 mmHg or
higher, or increase in heart rate of 30 bpm or higher within 2 to 3 minutes after
passing from a supine to a standing position at screening.
8. History of significant alcohol abuse within 1 year prior to screening or regular use
of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol
per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
9. History of significant drug abuse within 1 year prior to screening, or use of soft
drugs (such as marijuana) within 3 months prior to the screening visit, or hard drugs
(such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and
amphetamine derivatives) within 1 year prior to screening.
10. Subjects drinking excessive amounts of tea, coffee, or caffeinated beverages (more
than 8 cups,1 cup = 250 mL) every day before the screening, or those who cannot agree
to prohibit drinking tea, coffee, and/or products containing caffeine, grapefruit, or
poppy 24 hours before dosing and during the study period.
11. Smoking history of 5 cigarettes per day within 3 months before the study, or those who
cannot stop smoking 24 h before dosing and during the study period.
12. Have undergone major surgery 6 months before the study, or plan to have surgery during
the study.
13. Have been vaccinated within 3 months prior to the study.
14. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the first dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.
15. Use of medications for the time frames specified below, except for medications
prescribed by the Investigator on a case-by-case basis because they have been judged
unlikely to affect the pharmacokinetic profile of the study drug or subject safety
(e.g., topical drug products without significant systemic absorption):
1. Prescription medications within 14 days prior to the first dosing.
2. Over-the-counter products and natural health products (including herbal remedies,
homeopathic and traditional medicines, probiotics, food supplements such as
vitamins, minerals, amino acids, essential fatty acids, and protein supplements
used in sports) within 7 days prior to the first dosing, except for the
occasional use of acetaminophen (up to 2 g daily).
3. Depot injection or implantation of any drug within 3 months prior to the first
dosing.
4. Any drugs known to induce or inhibit hepatic drug metabolism (including St.
John's Wort) within 30 days prior to the first dosing.
16. Donation of plasma within 7 days prior to dosing. Donation or blood loss (excluding
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
499 mL within 56 days prior to the first dosing.
17. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study.
18. Breastfeeding subject.
19. Any history of suicidal ideation or suicidal behavior (within 2 years prior to
screening), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS;
baseline version).
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