Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
1
Ocular inflammatory conditions
Key facts
- Sponsor
- Dompe' Farmaceutici S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 16 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-09
- 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
Ocular inflammatory conditions
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10015943 | Eye inflammation | 100000004853 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dompe' Farmaceutici S.p.A.
- Sponsor organisation
- Dompe' Farmaceutici S.p.A.
- Address
- Via Santa Lucia 6
- City
- Milan
- Postcode
- 20122
- Country
- Italy
Scientific contact point
- Organisation
- Dompe' Farmaceutici S.p.A.
- Contact name
- Pier Adelchi Ruffini
Public contact point
- Organisation
- Dompe' Farmaceutici S.p.A.
- Contact name
- Julian Ariel Pastine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2026-02-16 | 2026-02-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-15 | Netherlands | Acceptable 2026-02-09
|
2026-02-09 |