MF-1 for Parkinson's (MF1-FIH, NCT07666022)
Stop harmful brain protein clumping
- 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
- Stop harmful brain protein clumping
- 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
Summary For Families
MF1 is a new medication being tested to stop the abnormal clumping of a brain protein called alpha-synuclein, which is thought to drive Parkinson's disease. In lab studies MF1 blocked that clumping and reduced brain inflammation, and this first-in-human trial will primarily check safety, side effects, and how the body absorbs and clears the drug. The study has three parts: single and short repeated doses in healthy volunteers to find safe dose levels and test the effect of food, and a 14-day treatment in a small group of people with Parkinson's to collect spinal fluid levels and markers of nerve injury and inflammation. Parts A and B enroll healthy Japanese men aged 18 to 44 with a normal body mass index, and Part C enrolls people aged 40 to 84 with mild to moderate Parkinson's (stage 3 or less) who are untreated or on stable doses of certain Parkinson's medicines; people with serious other illnesses, seizure history, certain infections, recent suicidal thoughts, or recent use of other experimental drugs are excluded.
Locations
- Sumida Hospital, Sumida-ku, Tokyo, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying MF-1. MF1 is a new medication being tested to stop the abnormal clumping of a brain protein called alpha-synuclein, which is thought to drive Parkinson's disease. In lab studies MF1 blocked that clumping and reduced brain inflammation, and this first-in-human trial will primarily check safety, side effects, and how the body absorbs and clears the drug. The study has three parts: single and short repeated doses in healthy volunteers to find safe dose levels and test the effect of food, and a 14-day treatment in a small group of people with Parkinson's to collect spinal fluid levels and markers of nerve injury and inflammation. Parts A and B enroll healthy Japanese men aged 18 to 44 with a normal body mass index, and Part C enrolls people aged 40 to 84 with mild to moderate Parkinson's (stage 3 or less) who are untreated or on stable doses of certain Parkinson's medicines; people with serious other illnesses, seizure history, certain infections, recent suicidal thoughts, or recent use of other experimental drugs are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- 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. Because assignment is random, you have about a 2 in 5 chance (roughly 40%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- 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.