Healthy Adult MalePhase 1NCT07666022
A Clinical Study to Evaluate the Safety of MF1, a New Treatment for Parkinson's Disease-related Disorders (MF1 Study)
A Phase 1 study testing MF-1 in people with Healthy Adult Male and PARKINSON DISEASE (Disorder), run by University of Shizuoka at 1 site in Japan.
Trial summary
This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male, PARKINSON DISEASE (Disorder)
- What is being tested?
- MF-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2026to 31 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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).
Show all 14Show fewer
- 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.
Who cannot join
- (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.
Show all 31Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Sumida Hospital
Sumida-ku, Tokyo, 130-0004
Yu Nemoto, PhD, +81-22-717-7136, yu.nemoto.b8@tohoku.ac.jp
Masanoir Fujiwara
About this study
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)
This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). MF1 aims to address the unmet medical need in PD, which affects about 1% of individuals aged 60 years and older in Japan and is projected to reach 43 million patients worldwide by 2050.
The trial consists of three parts: Part A (single ascending dose) and Part B (multiple ascending dose) in healthy Japanese male adults, and Part C (multiple dose) in patients with idiopathic PD. Part A is a randomized, double-blind, placebo-controlled, single-center study assessing single oral doses , including a food-effect evaluation. Part B is a randomized, double-blind, placebo-controlled, single-center study with once-daily dosing for 7 days. Part C is an open-label, multicenter study in 4-8 PD patients (MDS 2015 criteria, Hoehn \& Yahr stage ≤3) receiving once daily for 14 days, with or without stable background antiparkinsonian therapy.
Read more
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. Exploratory pharmacodynamic endpoints include biomarkers such as α-synuclein, neurofilament light chain, UCHL-1, FABP3, GFAP, and other neurodegeneration markers.
Key exclusion criteria include clinically significant systemic diseases, seizure history, serious infections (HBV, HCV, HIV, syphilis), recent suicidal ideation or attempts, and recent use of other investigational products.
Read the detailed description
- α-Synucleinopathies are a group of progressive neurodegenerative diseases caused by the pathological aggregation and prion-like propagation of α-synuclein protein, culminating in selective neuronal loss. Parkinson's disease (PD) represents the most prevalent form, affecting approximately 1% of individuals aged 60 years and older in Japan, with the global burden projected to reach 43 million patients by 2050. Despite decades of research, currently approved therapies remain restricted to symptomatic management targeting dopaminergic deficits and do not address the underlying mechanisms of α-synuclein misfolding, oligomerization, or cell-to-cell spread. No disease-modifying, neuroprotective, or neurorestorative therapy has been approved to date, representing a critical unmet medical need.
- MF1 is a novel investigational agent designed to target the pathophysiological mechanisms underlying α-synucleinopathy. Preclinical studies have demonstrated that MF1 inhibits α-synuclein aggregation and reduces neuroinflammatory cascades associated with dopaminergic neurodegeneration. Based on its mechanism of action, MF1 is expected to be a novel therapeutic agent targeting these pathological mechanisms, with the potential to confer both neuroprotective effects and clinically meaningful symptomatic benefits, thereby addressing this unmet medical need.
- This First-in-Human (FIH) Phase I trial employs a stepwise dose-escalation approach across three sequential parts to characterize the safety, tolerability, and pharmacokinetic (PK) profile of MF1. The three-part sequential dose-escalation design, incorporating single ascending doses (Part A) and multiple ascending doses (Part B) in healthy adult volunteers, followed by evaluation in a patient cohort (Part C), is consistent with established first-in-human (FIH) best practices and ensures systematic safety data review prior to advancement to each subsequent study part.
- The restriction to healthy Japanese males aged 18-44 years with BMI 18.5 to <25.0 kg/m² in Parts A and B is intended to minimize confounding variables during initial safety and PK characterization. Given that MF1 is intended for a patient population with a higher average age and potential co-morbidities, Part C enrolls patients with idiopathic PD under a more inclusive age range (40-84 years) and permits concomitant use of select stable antiparkinsonian medications to reflect real-world treatment conditions. The restriction to Hoehn \& Yahr stage ≤3 ensures that participants retain sufficient functional capacity for protocol compliance and limits confounding from advanced disease-related physiological changes.
- Food effect assessment in Part A is incorporated to characterize the influence of food intake on oral bioavailability of MF1, which will inform dosing recommendations for subsequent studies. CSF sampling in a subset of participants is planned to assess CNS penetration of MF1, a critical pharmacological prerequisite for a CNS-targeted agent. Exploratory pharmacodynamic assessments include established fluid biomarkers of neuronal injury and glial activation (α-synuclein, Nf-L, UCHL-1, FABP3, GFAP), which will provide mechanistic evidence of target engagement and serve as early signals for neuroprotective activity.
- The primary objectives of Part C are to assess the safety and tolerability profile in a small number of elderly subjects and to obtain pharmacokinetic data in this patient population, which will serve to support rational dose selection for subsequent phases of clinical development.
- Conditions
- Healthy Adult Male, PARKINSON DISEASE (Disorder)
- Being tested
- MF-1, Placebo
- Keywords
- FIH
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF-1Drug
Oral administration of MF1
PlaceboDrug
Indistinguishable from MF1
| Study group | Role | What they receive |
|---|---|---|
| MF1 single ascending dose (healthy) | Experimental | Single oral dose of MF1 in healthy male adults (Part A). Receives: Drug: MF-1 |
| Placebo single dose (healthy) | Placebo comparator | Single oral dose of placebo in healthy male adults (Part A). Receives: Drug: Placebo |
| MF1 multiple ascending doses (healthy) | Experimental | Once-daily oral doses of MF1 for 7 days in healthy male adults (Part B). Receives: Drug: MF-1 |
| Placebo multiple doses (healthy) | Placebo comparator | Once-daily oral doses of placebo for 7 days in healthy male adults (Part B). Receives: Drug: Placebo |
| MF1 multiple doses (Parkinson's disease) | Experimental | Once-daily oral doses of MF1 for 14 days in patients with Parkinson's disease (Part C). Receives: Drug: MF-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events and serious adverse events
The number and percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be summarized by treatment group and study part (Part A, Part B, Part C), including events leading to permanent discontinuation of study drug and clinically significant changes in vital signs, clinical laboratory tests, and 12-lead ECGs.
Measured: 12 days from last dosing
Maximum plasma concentration (Cmax) of MF1
Cmax will be determined from plasma concentration-time data following single and multiple oral doses of MF1 in healthy subjects (Parts A and B) and patients with Parkinson's disease (Part C)
Measured: 5 days after last dosing
Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC0-t) of MF1
AUC0-t will be calculated using the linear-log trapezoidal method from plasma concentration-time data following single and multiple oral doses of MF1
Measured: Time Frame: Pre-dose through 5 days after last dosing
Terminal elimination half-life (t1/2) of MF1
t1/2 will be calculated from the terminal slope of the plasma concentration-time profile following single and multiple oral doses of MF1
Measured: Pre-dose through 5 days after last dosing
Cerebrospinal fluid (CSF) concentration of MF1
CSF concentrations of MF1 will be determined at a predefined time point in healthy participants in single ascending last 2 doses（Part A） and patients with Parkinson's disease (Part C) to assess central nervous system penetration.
Measured: Pre-dose through 24 hours after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Collaborators
- Tohoku University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666022
- Sponsor's protocol ID
- C-72
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and key secondary outcome analyses may be shared with qualified researchers and collaborating pharmaceutical companies for the purpose of further development of the investigational product and related scientific research. IPD will be made available after completion of the primary analysis and publication of the main results of this trial, subject to approval by the investigator. Data will be provided in a de-identified format in which direct identifiers are removed and indirect identifiers are processed according to our institutional data protection policy, so that individual participants cannot reasonably be re-identified. Access to IPD will require a written research proposal, a data use agreement specifying the scope of use, data security measures, and prohibition of attempts at re-identification or unauthorized sharing of the data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07666022
- Acronym / sponsor ID
- C-72
- Conditions
- Healthy Adult Male, PARKINSON DISEASE (Disorder)
- Keywords
- FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Collaborators
- Tohoku University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). MF1 aims to address the unmet medical need in PD, which affects about 1% of individuals aged 60 years and older in Japan and is projected to reach 43 million patients worldwide by 2050.
The trial consists of three parts: Part A (single ascending dose) and Part B (multiple ascending dose) in healthy Japanese male adults, and Part C (multiple dose) in patients with idiopathic PD. Part A is a randomized, double-blind, placebo-controlled, single-center study assessing single oral doses , including a food-effect evaluation. Part B is a randomized, double-blind, placebo-controlled, single-center study with once-daily dosing for 7 days. Part C is an open-label, multicenter study in 4-8 PD patients (MDS 2015 criteria, Hoehn \& Yahr stage ≤3) receiving once daily for 14 days, with or without stable background antiparkinsonian therapy.
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. Exploratory pharmacodynamic endpoints include biomarkers such as α-synuclein, neurofilament light chain, UCHL-1, FABP3, GFAP, and other neurodegeneration markers.
Key exclusion criteria include clinically significant systemic diseases, seizure history, serious infections (HBV, HCV, HIV, syphilis), recent suicidal ideation or attempts, and recent use of other investigational products.
Detailed description
- α-Synucleinopathies are a group of progressive neurodegenerative diseases caused by the pathological aggregation and prion-like propagation of α-synuclein protein, culminating in selective neuronal loss. Parkinson's disease (PD) represents the most prevalent form, affecting approximately 1% of individuals aged 60 years and older in Japan, with the global burden projected to reach 43 million patients by 2050. Despite decades of research, currently approved therapies remain restricted to symptomatic management targeting dopaminergic deficits and do not address the underlying mechanisms of α-synuclein misfolding, oligomerization, or cell-to-cell spread. No disease-modifying, neuroprotective, or neurorestorative therapy has been approved to date, representing a critical unmet medical need.
- MF1 is a novel investigational agent designed to target the pathophysiological mechanisms underlying α-synucleinopathy. Preclinical studies have demonstrated that MF1 inhibits α-synuclein aggregation and reduces neuroinflammatory cascades associated with dopaminergic neurodegeneration. Based on its mechanism of action, MF1 is expected to be a novel therapeutic agent targeting these pathological mechanisms, with the potential to confer both neuroprotective effects and clinically meaningful symptomatic benefits, thereby addressing this unmet medical need.
- This First-in-Human (FIH) Phase I trial employs a stepwise dose-escalation approach across three sequential parts to characterize the safety, tolerability, and pharmacokinetic (PK) profile of MF1. The three-part sequential dose-escalation design, incorporating single ascending doses (Part A) and multiple ascending doses (Part B) in healthy adult volunteers, followed by evaluation in a patient cohort (Part C), is consistent with established first-in-human (FIH) best practices and ensures systematic safety data review prior to advancement to each subsequent study part.
- The restriction to healthy Japanese males aged 18-44 years with BMI 18.5 to <25.0 kg/m² in Parts A and B is intended to minimize confounding variables during initial safety and PK characterization. Given that MF1 is intended for a patient population with a higher average age and potential co-morbidities, Part C enrolls patients with idiopathic PD under a more inclusive age range (40-84 years) and permits concomitant use of select stable antiparkinsonian medications to reflect real-world treatment conditions. The restriction to Hoehn \& Yahr stage ≤3 ensures that participants retain sufficient functional capacity for protocol compliance and limits confounding from advanced disease-related physiological changes.
- Food effect assessment in Part A is incorporated to characterize the influence of food intake on oral bioavailability of MF1, which will inform dosing recommendations for subsequent studies. CSF sampling in a subset of participants is planned to assess CNS penetration of MF1, a critical pharmacological prerequisite for a CNS-targeted agent. Exploratory pharmacodynamic assessments include established fluid biomarkers of neuronal injury and glial activation (α-synuclein, Nf-L, UCHL-1, FABP3, GFAP), which will provide mechanistic evidence of target engagement and serve as early signals for neuroprotective activity.
- The primary objectives of Part C are to assess the safety and tolerability profile in a small number of elderly subjects and to obtain pharmacokinetic data in this patient population, which will serve to support rational dose selection for subsequent phases of clinical development.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MF1 single ascending dose (healthy) | Experimental | Drug: MF-1Single oral dose of MF1 in healthy male adults (Part A). |
| Placebo single dose (healthy) | Placebo comparator | Drug: PlaceboSingle oral dose of placebo in healthy male adults (Part A). |
| MF1 multiple ascending doses (healthy) | Experimental | Drug: MF-1Once-daily oral doses of MF1 for 7 days in healthy male adults (Part B). |
| Placebo multiple doses (healthy) | Placebo comparator | Drug: PlaceboOnce-daily oral doses of placebo for 7 days in healthy male adults (Part B). |
| MF1 multiple doses (Parkinson's disease) | Experimental | Drug: MF-1Once-daily oral doses of MF1 for 14 days in patients with Parkinson's disease (Part C). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- (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)
Key exclusion criteria (31 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF-1Oral administration of MF1 | Drug | MF1 multiple ascending doses (healthy), MF1 multiple doses (Parkinson's disease), MF1 single ascending dose (healthy) |
| PlaceboIndistinguishable from MF1 | Drug | Placebo multiple doses (healthy), Placebo single dose (healthy) |
Primary outcome
Number of participants with treatment-emergent adverse events and serious adverse events
Time frame: 12 days from last dosing
The number and percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be summarized by treatment group and study part (Part A, Part B, Part C), including events leading to permanent discontinuation of study drug and clinically significant changes in vital signs, clinical laboratory tests, and 12-lead ECGs.
Maximum plasma concentration (Cmax) of MF1
Time frame: 5 days after last dosing
Cmax will be determined from plasma concentration-time data following single and multiple oral doses of MF1 in healthy subjects (Parts A and B) and patients with Parkinson's disease (Part C)
Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC0-t) of MF1
Time frame: Time Frame: Pre-dose through 5 days after last dosing
AUC0-t will be calculated using the linear-log trapezoidal method from plasma concentration-time data following single and multiple oral doses of MF1
Terminal elimination half-life (t1/2) of MF1
Time frame: Pre-dose through 5 days after last dosing
t1/2 will be calculated from the terminal slope of the plasma concentration-time profile following single and multiple oral doses of MF1
Cerebrospinal fluid (CSF) concentration of MF1
Time frame: Pre-dose through 24 hours after last dosing
CSF concentrations of MF1 will be determined at a predefined time point in healthy participants in single ascending last 2 doses（Part A） and patients with Parkinson's disease (Part C) to assess central nervous system penetration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and key secondary outcome analyses may be shared with qualified researchers and collaborating pharmaceutical companies for the purpose of further development of the investigational product and related scientific research. IPD will be made available after completion of the primary analysis and publication of the main results of this trial, subject to approval by the investigator. Data will be provided in a de-identified format in which direct identifiers are removed and indirect identifiers are processed according to our institutional data protection policy, so that individual participants cannot reasonably be re-identified. Access to IPD will require a written research proposal, a data use agreement specifying the scope of use, data security measures, and prohibition of attempts at re-identification or unauthorized sharing of the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MF-1 in people with Healthy Adult Male and PARKINSON DISEASE (Disorder), run by University of Shizuoka at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MASANORI FUJIWARA (+81 22-717-7136, masanori.fujiwara.a5@tohoku.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events and serious adverse events (time frame: 12 days from last dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.