Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
54
Countries
1
Sites
2
Geographic Atrophy
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Geographic Atrophy
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 · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Authorised, recruitment pending | 16 | 2 |
| Rest of world
Georgia, United Kingdom, United States
|
— | 38 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
AEM with County Hosp. Cluj Napoca, Ophtalm. Build. 1st floor, Wrds 33,34,35, Clinicilor St, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
AEM in colab. with Arensia Clinics, 3rd floor, Wrds 1,2,3,4,5,6,7,Tudor Stefan Str,Bucharest, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-11 | Romania | Acceptable 2026-03-16
|
2026-03-23 |