Parkinson's Disease (PD)Phase 1NCT07630545
A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.
A Phase 1 study testing MTX325 in people with Parkinson's Disease (PD) and Mild to Moderate Parkinson's Disease, run by Mission Therapeutics at 18 sites in 4 countries.
Trial summary
The goal of this trial is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease. Parts 1-4 complete, Part 5 (multiple doses in patients with Parkinson's Disease) in progress. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease, Early Stage Parkinson's Disease
- What is being tested?
- MTX325
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 30 Nov 2023to 27 Dec 2027
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants aged ≥ 40 to ≤ 75 years.
- Male or female participants. Female participants of childbearing potential must be willing to use highly effective forms of contraception (refer to Section 9.7.1 for details on highly effective methods of contraception and definitions of women of childbearing potential and of fertile men):
- Body mass index (BMI) between 18 and 34.0 kg/m2, inclusive.
- If being treated with selective serotonin reuptake inhibitors (SSRIs) for anxiety/ depression, must be on a stable dose for 60 days prior to Day -1 and must remain on that dose for the remainder of the study.
- Must have had other causes of Parkinsonism excluded
- No clinically significant history of previous allergy/ sensitivity to MTX325 or any of the excipients contained within the IMP.
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- Participant with a negative urinary drugs of abuse (DOA) screen (excluding alcohol).
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen [HbsAg]) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No history of torsade de pointes or long QT syndrome and no heart failure, hypokalaemia, or any other additional cardiac risk factors if judged clinically significant in the opinion of the Investigator.
- No clinically significant abnormalities in vital signs during the screening period.
- Able to perform all protocol assessments and comply with the study visit schedule.
- Able and willing to provide informed consent.
- Clinically established PD as per MDS Criteria[
- Absence of dementia as shown by a baseline Montreal Cognitive Assessment (MoCA®)
- Healthy male and female (Part 1-2 only) participant, aged ≥ 18 to ≤ 55 years.
- Female participant of childbearing potential (Part 1-2 only)
- Female participant of non-childbearing potential (Part 1-2 only).
- Female participant (Part 1-2 only) with a negative pregnancy test at Screening visit.
- Female participant of menopausal status (Part 1-2 only) confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range.
- Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception
- Participant with a body weight of at least 50.0 kg and body mass index (BMI) of 1832 kg/m2. BMI = body weight (kg) / [height (m)]2.
- No clinically significant history of previous allergy / sensitivity to MTX325 or any of the excipients contained within the IMP.
- No clinically significant abnormal test results for serum biochemistry, haematology, coagulation
- Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 35 days (45 days Part 4 only) before first dose of IMP.
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen [HbsAg]) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead electrocardiogram (ECG)
- No clinically significant abnormalities in vital signs
- Participant must be available to complete the study (including all follow-up visits).
- Participant must satisfy an Investigator about his/her fitness to participate in the study.
- Participant must provide written informed consent to participate in the study.
- Participants with a negative COVID-19 test on admission (if required).
- Part 4 only: Participant with normal MRI performed within 3 months of dosing, as judged by the investigator.
- Part 4 - COMPLETED
- Participants who have had previous exposure to ionizing radiation from research studies
- Participant has any contraindication to arterial line insertion
- Inability to lie supine for up to 120 mins for PET procedures.
- Participant has any contra-indication to MRI as determined by screening procedures and MRI safety questionnaire
- Participant suffers from claustrophobia or needle phobia.
- Any history of allergy/atopy including drug-induced allergy or any history of severe cutaneous adverse reaction or other type 4/delayed-type hypersensitivity.
- Current or previous history of eosinophilia with either unknown cause, or where known, the inciting factor is not removed or avoided.
- Previous history of Erythema Multiforme and/or identified current risk factor(s) for Erythema
- Part 3 - COMPLETED
- Healthy male and female participant, ≥ 65 years of age.
- Female participant of non-childbearing potential.
- Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range.
- Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception
- Participant with a body weight of at least 50.0 kg and BMI of 18-32 kg/m2.
- No clinically significant history of previous allergy / sensitivity to MTX325 or any of the excipients contained within the IMP.
- No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses determined within 35 days before first dose of IMP.
- Participant with an estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation >60 mL/min/1.73 m2.
- Participant with a negative urinary drugs of abuse (DOA)
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen [HbsAg]) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead electrocardiogram (ECG)
- No clinically significant abnormalities in vital signs
- Participant must be available to complete the study (including all follow-up visits).
- Participant must satisfy an Investigator about his/her fitness to participate in the study.
- Participant must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorders or any significant medical conditions that would be likely to influence IMP absorption, or evidence of clinically significant central nervous system, respiratory, cardiovascular or metabolic dysfunction or other significant medical conditions with potential to impact participant safety or hinder interpretation of study results.
- Clinically significant neurologic disorder other than PD, including history of stroke within 12 months of Screening, seizure within 5 years of Screening, or head trauma with loss of consciousness within 6 months of Screening.
- Those with known PD risk genes (per medical history).
- Reside in a nursing home or assisted care facility.
- No more than 2 PD related freezing episodes or falls in the past 6 months.
- Any condition that may predispose participant to complications or technical difficulty with lumbar puncture, in the opinion of the Investigator.
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- Participants who have conditions that would preclude a lumbar puncture (LP), such as a local infection at the site
- Participant who has a history of clinically significant hypersensitivity to local anaesthesia, or its derivatives used during CSF collection or to any medication used to prepare the area of LP.
- Reports having experienced suicidal ideation (Type 4 on 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS©]
- Participants should not be in receipt of any known MATE2k substrates
- Plan to receive or administration of rotigotine, catechol-o-methyltransferase (COMT) inhibitors (e.g., entacapone, tolcapone or opicapone), neuroleptics, venlafaxine, NMN, nicotinamide riboside or non-selective Monoamine oxidase [MAO] inhibitors within 7 days or 5 half-lives (whichever is longer) prior to first dose and during the study conduct.
- Clinically significant abnormal test results for serum biochemistry, haematology, coagulation and/or urine analyses as determined within 45 days before first dose of IMP.
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Participant has any condition that, in the opinion of the investigator, is clinically significant and may put the participant at greater safety risk, influence response to study product, or interfere with study assessment.
- Inability to communicate well with the Investigators.
- Participation (dosed) in a NCE clinical study within the previous 3 months or five half lives
- Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- Female participants who are pregnant, breastfeeding or lactating.
- Clinically significant abnormalities in 12-lead electrocardiogram (ECG)
- Participants with recent COVID-19 infection without resolution of symptoms
- Participants who have received a COVID-19 vaccine injection from the Screening visit up to first dose of IMP
- A clinically significant history of drug or alcohol abuse within the past 2 years.
- Currently prescribed treatment for Parkinson's Disease symptoms.
- Any history of allergy/atopy including drug-induced allergy history of severe cutaneous adverse reaction or other type 4/delayed-type hypersensitivity.
- Current or previous history of eosinophilia with either unknown cause, or where known, the inciting factor is not removed or avoided.
- Previous history of Erythema Multiforme and/or identified current risk factor(s) for Erythema Multiforme
- Participant has any contra-indication to PET or MRI as determined by screening procedures and PET and MRI safety questionnaires as conducted by the site.
- Clinically significant history of previous allergy/ sensitivity to [18F] FDG.
- Participants who have had previous exposure to ionizing radiation
- Chronic kidney disease defined as glomerular filtration rate (GFR) 1.5 × the upper limit of normal (ULN) or ALT or AST >3 × ULN or if participant has Child-Pugh Class C cirrhosis or equivalent severe hepatic impairment.
- Hepatic disease or altered liver function as defined by total bilirubin >1.5 × the upper limit of normal (ULN) or ALT or AST >3 × ULN or if participant has Child-Pugh Class C cirrhosis or equivalent severe hepatic impairment.
- Patients with uncontrolled type I or type II diabetes (insulin or non-insulin dependent).
- Current symptomatic Hay fever or any history of hay fever involving more than nose and eyes.
- PART 1, 2 ,4 - COMPLETED
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Use of prescription or non-prescription drugs, excluding allowable drugs and contraception
- Reports having experienced suicidal ideation (Type 4 on 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS©] him/herself or others - Part 2 only.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units
- Inability to communicate well with the Investigators
- Participation (dosed) in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives
- Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- Vegans, vegetarians or other dietary restrictions (Part 1 food effect evaluation, only).
- Users of nicotine products
- Participants with an excessive habitual daily intake of caffeine
- Female participants who are pregnant, breastfeeding or lactating (Part 1-2 only).
- Participants with veins unsuitable for venepuncture and cannulation.
- Participants with recent COVID-19 infection without resolution of symptoms
- Participants who have received a COVID-19 vaccine injection
- Part 1 Treatment Period 2a (CSF sampling) Cohort(s) only:
- Participants who have criteria that would preclude a lumbar puncture (LP)
- Participant who has a history of clinically significant hypersensitivity to local anaesthesia
- Participant who has a history of clinically significant or major back pathology (lumbar) surgery
- Part 4 - COMPLETED
- Participants who have had previous exposure to ionizing radiation from research studies, such that, in combination with the exposure from this study, their exposure will be >10 mSv for the previous 12 months.
- Participant has any contraindication to arterial line insertion
- Inability to lie supine for up to 120 mins for PET procedures.
- Participant has any contra-indication to MRI
- Participant suffers from claustrophobia or needle phobia.
- Any history of allergy/atopy
- Current or previous history of eosinophilia with either unknown cause, or where known, the inciting factor is not removed or avoided.
- Previous history of Erythema Multiforme and/or identified current risk factor(s) for Erythema Multiforme
- Part 3 - COMPLETED
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Evidence of febrile illness within 1 week of first dose of IMP.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements or any medication known to prolong the QT/QTc interval within 35 days or 5 half-lives
- Evidence of clinically significant renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- History of torsade de pointes, heart failure, hypokalaemia, long QT syndrome or any other additional cardiac risk factors.
- A clinically significant history of drug or alcohol abuse
- Participants with an excess habitual daily intake of caffeine
- Inability to communicate well with the Investigators
- Participation in a NCE clinical study within the previous 3 months or five half-lives
- Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- Participants who have received a COVID-19 vaccine injection within 35 days prior to first dose of IMP.
- Users of nicotine products
- Participants with veins unsuitable for venepuncture and cannulation.
- Participants with recent COVID-19 infection with resolution of symptoms
Trial locations and contacts
18 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Sarah J Fritchley, PhD contact
18 sites in 4 countries
United Kingdom10 sites, 7 recruiting
- Recruiting
Cambridge Biomedical Research Centre, Cambridge
Cambridge
Caroline Williams-Gray, Dr
- Not yet recruiting
Neuroclnx, Glasgow
Glasgow
David Anderson, Dr
- Recruiting
Royal Liverpool University Hospital
Liverpool
Antonella Macherello, Dr
- Completed
Parexel
London
- Completed
Perceptive
London
- Completed
Simbec-Orion
Merthyr Tydfil
- Recruiting
Freeman Hospital, Newcastle Upon Tyne
Newcastle
Dr David Ledingham, Dr
- Recruiting
University Hospitals Plymouth NHS Trust, Derriford Hospital
Plymouth
Stephen Mullin, Dr
- Recruiting
Salford Hospital (Manchester)
Salford
Monty Silverdale, Professor
- Recruiting
Southampton General Hospital, Southampton
Southampton
Boyd Ghosh, Dr
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Lille, Institut Cœur Poumon
Lille
Prof David Davos, Professor
- Not yet recruiting
Hôpital Henri-Mondor (Créteil, AP-HP), Paris
Paris
Philippe Remy, Dr
- Recruiting
Pitie-Salpetriere Hospital, Paris
Paris
Louise-Laure Mariani, Professor
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse
Toulouse
Olivier Rascol, Professor
Australia3 sites, 3 recruiting
- Not yet recruiting
The Royal Adelaide Hospital
Adelaide
Thomas E Kimber, Professor
- Recruiting
Doherty Clinical Trials
Melbourne
Thomas Frisby, Dr
- Not yet recruiting
Monash Health, Kingston Centre
Melbourne
Niro Vijiaratnam, Dr
Germany1 site, 1 recruiting
- Not yet recruiting
Technische Universitaet Dresden, Dresden
Dresden
Bjoern Falkenburger, Dr
About this study
Official title: A Multi-part, Adaptive Phase 1, First Time in Human Study in Healthy Volunteers to Assess Safety, Tolerability and Pharmacokinetics (PK) Following Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) of MTX325, Including Option to Assess: a Single Dose in Elderly Participants; Multiple Doses in Patients With Parkinson's Disease (PD); Central Nervous System (CNS) Penetration, Biodistribution, and Biomarkers; and the Effect of Food on PK.
The goal of this trial is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease. Parts 1-4 complete, Part 5 (multiple doses in patients with Parkinson's Disease) in progress.
- Conditions
- Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease, Early Stage Parkinson's Disease
- Being tested
- MTX325, Placebo
- Keywords
- Parkinson's disease, MDS-UPDRS, CSF, Plasma, Biomarkers, Mild, Moderate, Hoehn and Yahr scale
- Medical subject headings
- Parkinson Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX325Drug
MTX325
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Parts 1 - 4 | Active comparator | MTX325 Active Oral Capsules - 1.5mg - 100mg These 4 parts are SAD, MAD, Elderly and PET biodistribution. Receives: Drug: MTX325 |
| Parts 1 - 3, and 5 | Placebo comparator | MTX325 Placebo Capsules - 50mg. Parts 1-3 are SAD, MAD and Elderly cohorts. Matched strength placebo capsules in Part 5 (PD participants) Receives: Other: Placebo |
| Part 4 | Active comparator | MTX325 Capsules - 20mg. Radiolabelled MTX325 solution for injection. This is a healthy volunteer PET study. Not placebo controlled. Receives: Drug: MTX325 |
| Part 5 | Active comparator | MTX325 - 20 mg Capsules Receives: Drug: MTX325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To assess the safety and tolerability of single ascending doses of MTX325, when administered to participants. Adverse Events will be collected. The following vital signs will be measured to form the safety and tolerability outcome- blood pressure, heart rate, oral body temperature, respiratory rate. Laboratory Safety analyses will include biochemistry, haematology, and urinalysis. 12-lead ECG will be performed to collect heart rate, RR interval, PR interval, QRS width, QT interval, and QTcF interval.
All participants who receive at least 1 dose of IMP will be included in the safety analysis.
Measured: up to 28 days post dose
Brain Biodistribution
To investigate the brain biodistribution in MTX325. This part of the protocol is intended to ascertain the biodistribution of MTX325 in the brain. Radiolabelled MTX325 will be injected and PET images taken to determine the whole brain and regions of interest distribution volume. MRI images will be performed to be able to co-register regions of interest.
Measured: MRI performed during screening period and PET performed on Day 1
Safety and Tolerability
To evaluate the safety and tolerability of MTX325 in untreated participants with mild to moderate idiopathic PD. Adverse Events will be collected. The following vital signs will be measured to form the safety and tolerability outcome - blood pressure, heart rate, oral body temperature, respiratory rate. Laboratory Safety analyses will include biochemistry, haematology, and urinalysis. 12-lead ECG will be performed to collect heart rate, RR interval, PR interval, QRS width, QT interval, and QTcF interval.
All participants who receive at least 1 dose of IMP will be included in the safety analysis.
Measured: up to 28 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either MTX325 or placebo
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mission Therapeutics
- Sponsor type
- Research network
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630545
- Sponsor's protocol ID
- MTX325-101
- Other IDs
- 2024-517310-15-01
- Status last verified
- Jul 2026
- First submitted
- 6 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-part, Adaptive Phase 1, First Time in Human Study in Healthy Volunteers to Assess Safety, Tolerability and Pharmacokinetics (PK) Following Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) of MTX325, Including Option to Assess: a Single Dose in Elderly Participants; Multiple Doses in Patients With Parkinson's Disease (PD); Central Nervous System (CNS) Penetration, Biodistribution, and Biomarkers; and the Effect of Food on PK.
- ClinicalTrials.gov ID
- NCT07630545
- Acronym / sponsor ID
- MTX325-101
- Conditions
- Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease, Early Stage Parkinson's Disease
- Keywords
- Parkinson's disease, MDS-UPDRS, CSF, Plasma, Biomarkers, Mild, Moderate, Hoehn and Yahr scale
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Mission TherapeuticsResearch network
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 5 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.
The goal of this trial is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease. Parts 1-4 complete, Part 5 (multiple doses in patients with Parkinson's Disease) in progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will receive either MTX325 or placebo
| Arm | Type | Receives |
|---|---|---|
| Parts 1 - 4 | Active comparator | Drug: MTX325MTX325 Active Oral Capsules - 1.5mg - 100mg These 4 parts are SAD, MAD, Elderly and PET biodistribution. |
| Parts 1 - 3, and 5 | Placebo comparator | Other: PlaceboMTX325 Placebo Capsules - 50mg. Parts 1-3 are SAD, MAD and Elderly cohorts. Matched strength placebo capsules in Part 5 (PD participants) |
| Part 4 | Active comparator | Drug: MTX325MTX325 Capsules - 20mg. Radiolabelled MTX325 solution for injection. This is a healthy volunteer PET study. Not placebo controlled. |
| Part 5 | Active comparator | Drug: MTX325MTX325 - 20 mg Capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (57 listed)
- Male and female participants aged ≥ 40 to ≤ 75 years.
- Male or female participants. Female participants of childbearing potential must be willing to use highly effective forms of contraception (refer to Section 9.7.1 for details on highly effective methods of contraception and definitions of women of childbearing potential and of fertile men):
- Body mass index (BMI) between 18 and 34.0 kg/m2, inclusive.
- If being treated with selective serotonin reuptake inhibitors (SSRIs) for anxiety/ depression, must be on a stable dose for 60 days prior to Day -1 and must remain on that dose for the remainder of the study.
- Must have had other causes of Parkinsonism excluded
Key exclusion criteria (77 listed)
- A clinically significant history of gastrointestinal disorders or any significant medical conditions that would be likely to influence IMP absorption, or evidence of clinically significant central nervous system, respiratory, cardiovascular or metabolic dysfunction or other significant medical conditions with potential to impact participant safety or hinder interpretation of study results.
- Clinically significant neurologic disorder other than PD, including history of stroke within 12 months of Screening, seizure within 5 years of Screening, or head trauma with loss of consciousness within 6 months of Screening.
- Those with known PD risk genes (per medical history).
- Reside in a nursing home or assisted care facility.
- No more than 2 PD related freezing episodes or falls in the past 6 months.
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 |
|---|---|---|
| MTX325MTX325 | Drug | Part 4, Part 5, Parts 1 - 4 |
| PlaceboPlacebo | Other | Parts 1 - 3, and 5 |
Primary outcome
Safety and Tolerability
Time frame: up to 28 days post dose
To assess the safety and tolerability of single ascending doses of MTX325, when administered to participants. Adverse Events will be collected. The following vital signs will be measured to form the safety and tolerability outcome- blood pressure, heart rate, oral body temperature, respiratory rate. Laboratory Safety analyses will include biochemistry, haematology, and urinalysis. 12-lead ECG will be performed to collect heart rate, RR interval, PR interval, QRS width, QT interval, and QTcF interval. All participants who receive at least 1 dose of IMP will be included in the safety analysis.
Brain Biodistribution
Time frame: MRI performed during screening period and PET performed on Day 1
To investigate the brain biodistribution in MTX325. This part of the protocol is intended to ascertain the biodistribution of MTX325 in the brain. Radiolabelled MTX325 will be injected and PET images taken to determine the whole brain and regions of interest distribution volume. MRI images will be performed to be able to co-register regions of interest.
Safety and Tolerability
Time frame: up to 28 days post dose
To evaluate the safety and tolerability of MTX325 in untreated participants with mild to moderate idiopathic PD. Adverse Events will be collected. The following vital signs will be measured to form the safety and tolerability outcome - blood pressure, heart rate, oral body temperature, respiratory rate. Laboratory Safety analyses will include biochemistry, haematology, and urinalysis. 12-lead ECG will be performed to collect heart rate, RR interval, PR interval, QRS width, QT interval, and QTcF interval. All participants who receive at least 1 dose of IMP will be included in the safety analysis.
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 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sarah J Fritchley, PhD contact
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTX325 in people with Parkinson's Disease (PD) and Mild to Moderate Parkinson's Disease, run by Mission Therapeutics at 18 sites in 4 countries.
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 57 inclusion and 77 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, France, Australia, Germany. 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 Sarah J Fritchley, PhD (sfritchley@missiontherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: up to 28 days post dose). The study lists 3 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 20 Oct 2026.