Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
68
Countries
1
Sites
1
Parkinson's disease
Key facts
- Sponsor
- Teitur Trophics ApS
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-13
- 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's disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teitur Trophics ApS
- Sponsor organisation
- Teitur Trophics ApS
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Teitur Trophics ApS
- Contact name
- Philip Kremer
Public contact point
- Organisation
- Teitur Trophics ApS
- Contact name
- Philip Kremer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 68 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Neurology, Zernikedreef 8, 2333 CL, Leiden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-06-13 | 2025-06-18 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-28 | Netherlands | Acceptable 2025-06-12
|
2025-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-25 | Netherlands | Acceptable 2025-07-02
|
2025-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-13 | Netherlands | Acceptable 2025-12-03
|
2025-12-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-16 | Netherlands | Acceptable 2026-03-10
|
2026-03-11 |