A multi-part study to investigate MTX325 in healthy volunteers and patients with Parkinson's Disease

2024-517310-15-00 Protocol MTX325-101 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 3 EU/EEA countries · 8 sites · Protocol MTX325-101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 136
Countries 3
Sites 8

Parkinson's Disease

Key facts

Sponsor
Mission Therapeutics Limited
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Decision date (initial)
2026-05-18
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-517310-15-00
ISRCTN
ISRCTN20898392

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Parkinson's Disease

VersionLevelCodeTermSystem organ class
20.0 PT 10061536 Parkinson's disease 100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mission Therapeutics Limited

Sponsor organisation
Mission Therapeutics Limited
Address
Babraham Hall, Babraham Babraham
City
Cambridge
Postcode
CB22 3AT
Country
United Kingdom

Scientific contact point

Organisation
Mission Therapeutics Limited
Contact name
Chief Development Officer

Public contact point

Organisation
Mission Therapeutics Limited
Contact name
Chief Development Officer

Locations

3 EU/EEA countries · 8 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 6 4
Germany Authorised, recruitment pending 6 3
Netherlands Authorised, recruitment pending 6 1
Rest of world
United Kingdom, Australia
118

Investigational sites

France

4 sites · Authorised, recruitment pending
Assistance Publique Hopitaux De Paris
Neurology CEC Neurosciences, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Hospices Civils De Lyon
Hopital neurologique Pierre Wertheimer/Neurologie C, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Lille
Neuropharmacologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire De Toulouse
Pharmacologie Cliniqu, 2 Rue Viguerie, 31300, Toulouse

Germany

3 sites · Authorised, recruitment pending
Technische Universitaet Dresden
Klinik und Poliklinik fUr Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
LMU Klinikum Muenchen AöR
Neurology dep., Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Duesseldorf AöR
Neurology dep., Moorenstrasse 5, Bilk, Duesseldorf

Netherlands

1 site · Authorised, recruitment pending
Centre for Human Drug Research
Neurology dep., Zernikedreef 8, 2333 CL, Leiden

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-01-28 Germany Acceptable
2026-05-18
2026-05-18