Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
28
Countries
1
Sites
1
Parkinson Disease
Key facts
- Sponsor
- Modag GmbH
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-05-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Parkinson Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
| 21.1 | PT | 10064060 | Multiple system atrophy | 100000004852 |
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Modag GmbH
- Sponsor organisation
- Modag GmbH
- Address
- Mikro-Forum-Ring 3
- City
- Wendelsheim
- Postcode
- 55234
- Country
- Germany
Scientific contact point
- Organisation
- Modag GmbH
- Contact name
- Prof. Dr. Levin
Public contact point
- Organisation
- Modag GmbH
- Contact name
- Prof. Dr. Levin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 28 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-13 | Germany | Acceptable 2026-04-20
|
2026-05-04 |