MF-1 for Parkinson's (MF1-FIH, NCT07666022)
New medication slows Parkinson progression
- Trial ID
- NCT07666022
- Official Title
- A Phase I Investigator-initiated First-in-human Study to Evaluate the Safety and Pharmacokinetics of MF1 in Healthy Adults and Patients With Parkinson's Disease (MF1-FIH)
- Study Acronym
- MF1-FIH
- Goal
- New medication slows Parkinson progression
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- University of Shizuoka
- Study Type
- INTERVENTIONAL
- Enrollment
- 58 participants
- Conditions
- Healthy Adult Male, PARKINSON DISEASE (Disorder)
- Interventions
- MF-1, Placebo
- Registry Record Last Updated
- 2026-06-24 (1 month ago)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: invasive procedure, placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
The goal is to test MF1, a new oral drug that aims to stop harmful clumping of a brain protein called alpha-synuclein and the inflammation that follows, with the hope of slowing the nerve damage that drives Parkinson's instead of only treating symptoms. The study is a first-in-human Phase 1 that first gives single and short repeated doses to healthy volunteers to check safety, tolerability, blood and spinal fluid levels, and food effects, then gives once-daily doses for 14 days to a small group of people with Parkinson's while measuring safety and early biological markers. Parts A and B enroll healthy Japanese men aged 18 to 44 with a normal body mass index, and Part C enrolls 4, 8 people with idiopathic Parkinson's (Parkinson's not caused by another condition) aged 40 to 84 at stage 3 or earlier who may be on certain stable Parkinson's medications. People with seizure disorders, serious systemic illnesses, active serious infections, recent suicidal thoughts or recent use of other investigational drugs are not eligible.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 1 to 5
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "at a stable dosage regimen for at least 8 weeks prior to screening")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "(e.g., pallidotomy, deep brain stimulation, or fetal tissue transplantation).")
- Healthy volunteers: Also accepts people without Parkinson's (healthy volunteers) (criteria text: "CT.gov structured field: healthyVolunteers")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people up to age 85.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires Hoehn and Yahr stage 1 to 5.
Locations
- Sumida Hospital, Sumida-ku, Tokyo, Japan
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07666022. It is the one about "New medication slows Parkinson progression". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 5 groups, and 2 are placebo groups. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying MF-1. The goal is to test MF1, a new oral drug that aims to stop harmful clumping of a brain protein called alpha-synuclein and the inflammation that follows, with the hope of slowing the nerve damage that drives Parkinson's instead of only treating symptoms. The study is a first-in-human Phase 1 that first gives single and short repeated doses to healthy volunteers to check safety, tolerability, blood and spinal fluid levels, and food effects, then gives once-daily doses for 14 days to a small group of people with Parkinson's while measuring safety and early biological markers. Parts A and B enroll healthy Japanese men aged 18 to 44 with a normal body mass index, and Part C enrolls 4, 8 people with idiopathic Parkinson's (Parkinson's not caused by another condition) aged 40 to 84 at stage 3 or earlier who may be on certain stable Parkinson's medications. People with seizure disorders, serious systemic illnesses, active serious infections, recent suicidal thoughts or recent use of other investigational drugs are not eligible.
- Who can participate?
- Participants must be between 18 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 5 groups, and 2 are placebo groups. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive). Confirm the full schedule with the study coordinator.