Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
15
Countries
1
Sites
1
Uveal melanoma
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11], Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jun 2026 → ongoing
- Decision date (initial)
- 2026-02-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Uveal melanoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Nordre Fasanvej 57
- City
- Frederiksberg
- Postcode
- 2000
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Inge Marie Svane
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Inge Marie Svane
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruiting | 15 | 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 |
|---|---|---|---|---|---|
| Denmark | 2026-06-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-17 | Denmark | Acceptable 2026-02-04
|
2026-02-04 |