Phase 1 Study to Evaluate Safety, Tolerability, and Brain Effects of MTX325 in Healthy Adults and Parkinsons Disease Patients

What this Trial Is About

Researchers are studying MTX325 as a potential treatment to modify the progression of Parkinsons Disease PD. This Phase 1 trial includes healthy volunteers and patients with mild to moderate, early-stage Parkinsons Disease. The study aims to evaluate safety, tolerability, pharmacokinetics, brain biodistribution, and the effect of food on the drug. Parts 1 to 4 of the study, involving single and multiple ascending doses as well as elderly participants and PET biodistribution, have been completed. Part 5, which assesses multiple doses in PD patients, is currently ongoing. Participants receive MTX325 in different doses as oral capsules or placebo capsules depending on the study part. In some parts, a radiolabelled MTX325 solution is used for PET imaging in healthy volunteers to assess central nervous system penetration and biodistribution. The study uses a randomized, parallel design with several parts examining single ascending doses, multiple ascending doses, elderly subjects, and patients with Parkinsons Disease. PET scans and MRI are used during screening and on dosing days to study brain biodistribution. During the trial, participants undergo safety and tolerability assessments up to 28 days after dosing. Screening includes MRI, PET scans, clinical evaluations, and laboratory tests such as HIV, hepatitis, and drug abuse screening. Participants are monitored for vital signs and adverse events, and cognitive assessments are performed to exclude dementia. The study involves scheduled visits for dosing, imaging, and follow-up to measure safety, drug distribution in the brain, and pharmacokinetics. Participation duration varies by study part, with some completed and others ongoing until late 2027.

A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.