The goal of this study is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease.
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.
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.
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
