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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMission Therapeutics

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MTX325
  • Placebo

Treatment groups

106 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Mission Therapeutics

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Parkinson's UK

Collaborator