Actively Recruiting
A Multi-part, Adaptive Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics, and Brain Biodistribution of MTX325 in Healthy Volunteers and Parkinson's Disease Patients
Led by Mission Therapeutics · Updated on 2026-06-05
106
Participants Needed
5
Research Sites
25 weeks
Total Duration
On this page
Sponsors
M
Mission Therapeutics
Lead Sponsor
M
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MTX325 as a potential disease-modifying treatment for Parkinson's Disease. This multi-part, first-time-in-human Phase 1 study includes healthy volunteers and participants with mild to moderate or early-stage Parkinson's Disease. The study aims to assess safety, tolerability, pharmacokinetics, brain biodistribution, and the effect of food on MTX325, led by Mission Therapeutics. The study includes several parts: single ascending dose (SAD), multiple ascending dose (MAD), elderly participant dosing, and a PET biodistribution study. Participants receive either MTX325 capsules at various doses or matched placebo capsules, depending on the study part. The PET study involves radiolabeled MTX325 injections for healthy volunteers. Different cohorts focus on healthy participants, elderly, and Parkinson's Disease patients. Participants undergo screening with MRI and PET scans, blood tests, ECG, vital signs, and urine drug screens. Safety and tolerability are monitored up to 28 days after dosing. Brain biodistribution is measured by MRI during screening and PET on dosing day. Participants must complete all study visits and provide informed consent. The study includes follow-up assessments to evaluate safety and pharmacokinetic outcomes over several weeks.
CONDITIONS
Brief Title
A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 18 to 55 years for Parts 1 and 2
- Male and female participants aged 65 years or older for Part 3
- Male and female participants aged 40 to 75 years with Parkinson's Disease for Part 5
- Female participants of childbearing or non-childbearing potential with negative pregnancy tests where applicable
- Participants with body weight of at least 50 kg and BMI within specified ranges
- Negative tests for HIV, hepatitis B and C, and drugs of abuse
- No clinically significant abnormalities in blood tests, ECG, or vital signs
- Ability to complete study and follow-up visits
- Provide written informed consent
- Negative COVID-19 test if required
- For Part 4, normal MRI within 3 months prior to dosing
You will not qualify if you...
- History of gastrointestinal disorders affecting drug absorption
- Use of prescription or non-prescription drugs not allowed by the study
- History of suicidal ideation (Part 2 only)
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction
- History of drug or alcohol abuse
- Inability to communicate with investigators
- Participation in other clinical trials with new chemical entities recently
- Recent blood donation exceeding 450 mL
- Dietary restrictions such as vegan or vegetarian (Part 1 only)
- Users of nicotine products or excessive caffeine intake
- Pregnant, breastfeeding, or lactating females (Parts 1 and 2)
- Unsuitable veins for venepuncture
- Recent COVID-19 infection or vaccination within specified periods
- Contraindications to MRI, PET, or arterial line insertion
- History of allergies, atopy, or severe skin reactions
- Clinically significant neurologic disorders other than Parkinson's (Part 5)
- Residence in nursing or assisted care facilities (Part 5)
- Use of certain medications interfering with the study drug (Part 5)
- Clinically significant abnormal test results or conditions judged unsafe by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including MRI for healthy volunteers in Part 4
Duration - Up to 28 days post dose
Participants receive MTX325 or placebo capsules as part of different study parts, including single and multiple ascending doses and PET biodistribution assessments.
Multiple visits depending on study part, including PET on Day 1 for biodistribution assessment
Duration - Up to 28 days post dose
Participants are monitored for safety and tolerability following dosing.
Several follow-up visits for safety assessments
Trial Site Locations
Total: 5 locations
1
Royal Liverpool University Hospital
Liverpool, United Kingdom
Actively Recruiting
2
Parexel
London, United Kingdom
Completed
3
Perceptive
London, United Kingdom
Completed
4
Simbec-Orion
Merthyr Tydfil, United Kingdom
Completed
5
University Hospitals Plymouth NHS Trust, Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
Research Team
S
Sarah J Fritchley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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