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.
Male and female participants aged ≥ 40 to ≤ 75 years.
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
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.
Parallel
MTX325
DrugMTX325
Placebo
Other interventionPlacebo
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.
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.
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.
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Mission Therapeutics
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Parkinson's UK
Collaborator
