ClinicaliQ Trial Snapshot
- A Phase I Study in Healthy Volunteers and Parkinson’s Disease (PD) Patients. — Recruiting • Phase I • Neurology • NCT07630545.
- What is being tested: MTX325 is being evaluated as a potential disease-modifying treatment for Parkinson's Disease, assessed initially in healthy volunteers for safety and tolerability before progression to PD patients.
- Patient eligibility overview: The study includes two populations—healthy volunteers for initial Phase I safety assessment, and Parkinson's Disease patients for preliminary efficacy and tolerability evaluation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this study is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease.
Eligibility Snapshot
- : Part 1, 2 ,4 1. Healthy male and female (Part 1-2 only) participant, aged ≥ 18 to ≤ 55 years. 2. Female participant of childbearing potential (Part 1-2 only) 3. Female participant of non-childbearing potential (Part 1-2 only). 4. Female participant (Part 1-2 only) with a negative pregnancy test at Screening visit. 5. Female participant of menopausal status (Part 1-2 only) confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. 6. Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception
- Participant with a body weight of at least 50.0 kg and body mass index (BMI) of 1832 kg/m2. BMI = body weight (kg) / [height (m)]2. 8. No clinically significant history of previous allergy / sensitivity to MTX325 or any of the excipients contained within the IMP. 9. No clinically significant abnormal test results for serum biochemistry, haematology, coagulation
- Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 35 days (45 days Part 4 only) before first dose of IMP.
- Participant with negative human immunodeficiency virus (HIV), hepatitis…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.