---
title: Stop harmful brain protein clumping
nct_id: NCT07666022
acronym: MF1-FIH
phase: PHASE1
status: RECRUITING
sponsor: University of Shizuoka
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07666022"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07666022"
last_fetched: "2026-06-24T14:00:11.906Z"
source: "Parkinson's Pathways (curated)"
---
# Stop harmful brain protein clumping

**Goal (in five words):** Stop harmful brain protein clumping

**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

**Trial ID:** [NCT07666022](https://clinicaltrials.gov/study/NCT07666022)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University of Shizuoka
- **Target Enrollment:** 58 participants
- **Start Date:** 2026-06-01
- **Completion Date:** 2028-09-30
- **Conditions:** Healthy Adult Male, PARKINSON DISEASE (Disorder)
- **Interventions:** MF-1, Placebo
- **Intervention Types:** DRUG

## 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.

## What This Actually Involves

**Placebo** _(From the protocol)_: 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.

**Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period.

**Procedures** _(From the protocol)_:
- Lumbar puncture (spinal tap) (Invasive)
  > "The primary objective is to assess safety and tolerability; secondary objectives include characterization of plasma, urine, and cerebrospinal fluid pharmacokinetics and assessment of food effect."

**Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long.

**Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered.

_Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

(Parts A and B)

* 1)Healthy Japanese male adults aged \>=18 and \<45 years at the time of informed consent.
* 2\) Subjects with a body mass index (BMI) of \>=18.5 and \<25.0 kg/m2 at screening.
* 3\) Subjects who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.

(Part C)

* 1\) Patients diagnosed with idiopathic Parkinson's disease according to the International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
* 2\) Patients with Parkinson's disease classified as Stage 3 or below according to the modified Hoehn and Yahr staging scale.
* 3\) Patients who are either untreated or have been receiving one of the following treatments at a stable dosage regimen for at least 8 weeks prior to screening, with no planned changes during the study period: selegiline up to 5 mg twice daily, rasagiline up to 1 mg once daily, or immediate-release carbidopa/levodopa up to 25/100 mg three times daily.
* 4\) Patients with an average Bristol Stool Scale score of \<=3 from the date of informed consent to eligibility assessment, or patients with fewer than two bowel movements per week.

If the period between informed consent and eligibility assessment is less than one week, information prior to informed consent will also be collected to assess bowel conditions for at least one week in total.

* 5\) Male or female patients aged \>=40 and \<85 years at the time of informed consent.
* 6\) Patients with a BMI of \>=18.5 and \<32.0 kg/m2 at screening.
* 7\) Female patients who are postmenopausal for at least one year at the time of informed consent, including menopause resulting from hysterectomy or oophorectomy.
* 8\) Patients who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.

Exclusion Criteria:

(Parts A and B)

* 1\) Subjects with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.
* 2\) Subjects with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.
* 3\) Subjects who used any medication, including over-the-counter drugs, within 7 days prior to the day before the first administration of the investigational product.
* 4\) Subjects with seizure disorders such as epilepsy, or a history thereof.
* 5\) Subjects with allergies or a history of allergies to drugs or foods.
* 6\) Subjects with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.
* 7\) Subjects with current or past alcohol or drug dependence.
* 8\) Subjects who donated \>=400 mL of whole blood within 12 weeks, \>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.
* 9\) Subjects who tested positive at screening for HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology (TP antibody test or RPR test).
* 10\) Subjects unwilling to use appropriate contraception from the time of informed consent until the final study visit.
* 11\) Subjects who answered "Yes" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.
* 12\) Subjects who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.
* 13\) Subjects judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.

(Part C)

* 1\) Patients with drug-induced parkinsonism, metabolic neurogenetic disorders, encephalitis, Parkinson-plus syndromes, or other atypical parkinsonian syndromes.
* 2\) Patients with freezing of gait.
* 3\) Patients with a history of stereotactic brain surgery for Parkinson's disease (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplantation).
* 4\) Patients with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders other than Parkinson's disease, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.
* 5\) Patients with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.
* 6\) Patients with seizure disorders such as epilepsy, or a history thereof.
* 7\) Patients currently receiving antiplatelet agents or anticoagulants.
* 8\) Patients with allergies or a history of allergies to drugs or foods.
* 9\) Patients with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.
* 10\) Patients with current or past alcohol or drug dependence.
* 11\) Patients who donated \>=400 mL of whole blood within 16 weeks, \>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.
* 12\) Patients who tested positive at screening for HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology (TP antibody test or RPR test).
* 13\) Patients unwilling to use appropriate contraception from the time of informed consent until the final study visit.
* 14\) Patients who answered "Yes" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.
* 15\) Patients who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.
* 16\) Patients judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.
```

## Locations (1)

- Sumida Hospital, Sumida-ku, Tokyo, Japan
  - Yu Nemoto, PhD, (CONTACT), +81-22-717-7136, yu.nemoto.b8@tohoku.ac.jp
  - Masanoir Fujiwara, (CONTACT)
  - Rie Yazawa, MD, (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- MASANORI FUJIWARA, (CONTACT), +81 22-717-7136, masanori.fujiwara.a5@tohoku.ac.jp

---

*Canonical: https://parkinsonspathways.com/trial/NCT07666022*  
*HTML version: https://parkinsonspathways.com/trial/NCT07666022*  
*Source data: https://clinicaltrials.gov/study/NCT07666022*