Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
128
Countries
1
Sites
1
SARS-CoV-2 (COVID-19)
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 28 Nov 2023 → 5 Mar 2025
- Decision date (initial)
- 2023-08-16
- 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
SARS-CoV-2 (COVID-19)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10051905 | Coronavirus infection | 100000004862 |
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 |
|---|---|---|---|
| Belgium | Ended | 128 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2023-11-28 | 2025-03-04 | 2023-11-28 | 2024-02-15 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | Belgium | Acceptable 2023-08-10
|
2023-08-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-18 | Belgium | Acceptable 2023-11-09
|
2023-11-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-27 | Belgium | Acceptable 2023-11-09
|
2024-02-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-06 | Belgium | Acceptable 2023-11-09
|
2024-06-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-13 | Belgium | Acceptable 2023-11-09
|
2024-11-13 |