Single and Multiple Ascending Dosing Administration of MF-300 in Healthy Participants (NCT07613684) | Clinical Trial Compass
CompletedPhase 1
Single and Multiple Ascending Dosing Administration of MF-300 in Healthy Participants
United States100 participantsStarted 2024-12-20
Plain-language summary
The study will consist of 2 parts, Study Parts 1 (1a: single ascending dose \[SAD\] Phase; and 1b: Food Effect Phase) and Part 2 (multiple ascending dose \[MAD\] Phase). The SAD and MAD phases will evaluate separately non-elderly (≥ 18 to ≤ 65 years of age) and elderly (\> 65 to ≤75 years of age) healthy adult subjects.
Who can participate
Age range
18 Years – 75 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
. Healthy male or non-pregnant, non-lactating female subjects ≥ 18 to ≤ 65 years of age at time of first dosing.
. Body mass index (BMI) within the range ≥ 18.0 to ≤ 35.0 kg/m2.
. Subjects in the food effect cohort must be willing to eat a high fat breakfast, including butter and turkey bacon or sausage.
. Female subjects must either:
. have no childbearing potential by reason of surgery (e.g., hysterectomy, bilateral oophorectomy, salpingectomy in documented medical history) or be at least 1 year post-menopausal (e.g., 12 months without menstrual period without other medical cause), and have menopause confirmed with follicle-stimulating hormone level of \>40 IU/L at screening in women not taking hormone contraceptive or hormone replacement therapy. Note: Documentation can come from the study center personnel's: review of the subject's medical records, medical examination, or medical history interview.
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
Proportion of participants with treatment-emergent adverse events (TEAEs)
Timeframe: From admission on Day -1 to the Follow-up End of Study Visit (Day 7 for Part 1a, Day 13 for Part 1b, and Day 11 for Part 2)
2
Proportion of participants with serious adverse events (SAEs)
Timeframe: From admission on Day -1 to the Follow-up End of Study Visit (Day 7 for Part 1a, Day 13 for Part 1b, and Day 11 for Part 2)
3
Proportion of participants with any TEAE leading to premature discontinuation of study intervention
Timeframe: From admission on Day -1 to the Follow-up End of Study Visit (Day 7 for Part 1a, Day 13 for Part 1b, and Day 11 for Part 2)
. if of child-bearing potential, must be truly abstinent of heterosexual intercourse as their usual and preferred lifestyle practicing abstinence and agree to remain abstinent for the duration of the study or subject's heterosexual partner is non-fertile (e.g. at least 90 days post-vasectomy from screening) or subjects are using and willing to continue using two medically acceptable forms of birth control for at least 30 days prior to screening (at least 90 days for oral and transdermal contraceptives) and at least 30 days after the last study drug administration. Acceptable forms of contraception include: bilateral tubal ligation or occlusion, oral or injectable hormonal contraceptives, contraceptive patch, hormonal and non-hormonal intra uterine devices, vaginal hormonal rings, vaginal diaphragm, or cervical caps, in addition to having their male partner use a condom plus spermicide agent.
. Male subjects must be non-fertile, vasectomized (vasectomy performed 4 months or more prior to the first dosing), or truly abstinent of heterosexual intercourse as their usual and preferred lifestyle and agree to remain abstinent for duration of study and for 90 days from last administration of study drug or heterosexual partner is not of child bearing potential or subject is willing to continue using two medically acceptable form of birth control from Day -1 until at least 90 days after the last administration of study drug. Highly effective contraceptive methods include:
. Use of a condom plus spermicide agent from the time of informed consent until 90 days after the last administration of study drug.
Exclusion criteria
. History of or current clinically significant medical illness including, but not limited to, any cardiovascular disease (including blood pressure or rhythm disturbance requiring constant monitoring), hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, or any other illness that the Investigator considers should exclude the subject or that could interfere with the safety of the subjects, or might confound the study results.
. Has cancer (Note: subject with history of cancer that is in complete remission and not requiring treatment for at least 5 years, including basal cell carcinoma, squamous cell skin cancer, or melanoma in situ superficial skin lesions that have been successfully removed, will not be exclusionary).
. Has acute or chronic GI conditions (e.g., gastroesophageal reflux disease, peptic ulcer, active and chronic colitis, cholecystectomy, small or large bowel resection, gastric bypass or equivalent) that would interfere with drug tolerance or absorption.
. Has history of migraine headaches requiring medical attention or active treatment within the past 6 months from screening.
. Has visible sunburn at admission
. Has a history of hypersensitivity/photosensitivity dermatosis within the past 5 years,
. Has another active dermatological pathology at screening or admission excluding dry skin or acne, deemed clinically significant by the Investigator.
. Has a history of or active ocular pathology or clinically significant findings in the Investigator opinion on ophthalmology exam at screening (Note: normal slit exam (glaucoma, cataract) will be sufficient to exclude sensitivity to phototoxicity).