A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets (NCT05660863) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets
16 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Healthy as defined by:
. 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.
. 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:
. 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
. surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration).
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of TEAEs and SAEs
Timeframe: Through study completion, an average of 12 days
2
Incidence and severity of treatment-related adverse events
Timeframe: Through study completion, an average of 12 days
. 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.
. History of allergic reactions to MN-08 or other related drugs, or to any excipient in the formulation.
. Positive pregnancy test at screening.
. 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.
. 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 \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).