New medication slows Parkinson progression
- Trial ID
- NCT07630545
- 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.
- Goal
- New medication slows Parkinson progression
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Mission Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 106 participants
- Conditions
- Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease, Early Stage Parkinson's Disease
- Interventions
- MTX325, Placebo
Summary For Families
The goal is to find out if MTX325 is safe, well tolerated, and reaches the brain in humans, while measuring how the body absorbs and clears it and whether it changes Parkinson's-related biomarkers. MTX325 is an experimental drug given in single and repeated doses versus placebo to map pharmacokinetics, test CNS penetration with CSF and imaging, check biodistribution, and assess the effect of food; the team will watch for any interactions with common Parkinson's medications and exclude or restrict some drugs in certain parts. The trial enrolls healthy adults 18 to 55 for initial dosing, a separate healthy older group aged 65 and up, and a Parkinson's cohort aged 40 to 75 with clinically established mild to moderate PD and no dementia, all subject to standard safety exclusions like major organ disease or recent drug or alcohol misuse. If you are considering joining, expect screening tests, imaging or lumbar puncture in some parts, and careful review of current medications.
Locations
- Royal Liverpool University Hospital, Liverpool, United Kingdom
- Parexel, London, United Kingdom
- Perceptive, London, United Kingdom
- Simbec-Orion, Merthyr Tydfil, United Kingdom
- University Hospitals Plymouth NHS Trust, Derriford Hospital, Plymouth, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying MTX325. The goal is to find out if MTX325 is safe, well tolerated, and reaches the brain in humans, while measuring how the body absorbs and clears it and whether it changes Parkinson's-related biomarkers. MTX325 is an experimental drug given in single and repeated doses versus placebo to map pharmacokinetics, test CNS penetration with CSF and imaging, check biodistribution, and assess the effect of food; the team will watch for any interactions with common Parkinson's medications and exclude or restrict some drugs in certain parts. The trial enrolls healthy adults 18 to 55 for initial dosing, a separate healthy older group aged 65 and up, and a Parkinson's cohort aged 40 to 75 with clinically established mild to moderate PD and no dementia, all subject to standard safety exclusions like major organ disease or recent drug or alcohol misuse. If you are considering joining, expect screening tests, imaging or lumbar puncture in some parts, and careful review of current medications.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- 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 3 years and 7 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.