Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
46
Countries
1
Sites
1
Parkinson's disease
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 20 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521431-37-00
- ClinicalTrials.gov
- NCT07216066
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
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 23 | 1 |
| Rest of world
Canada
|
— | 23 | — |
Investigational sites
Centre for Human Drug Research
Center for Human Drug Research, 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 | 2025-11-20 | 2025-12-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-30 | Netherlands | Acceptable with conditions 2025-11-17
|
2025-11-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-27 | Netherlands | Acceptable with conditions 2025-11-17
|
2025-11-27 |