Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
12
Countries
1
Sites
1
Diabetic retinopathy.
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2025-04-08
- 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
Diabetic retinopathy.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Rafael Simó
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Rafael Simó
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 12 | 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 | 2024-12-19 | Spain | Not acceptable 2025-04-03
|
2025-04-08 |