Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
34
Countries
1
Sites
1
Ulcerative colitis
Key facts
- Sponsor
- Faes Farma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 28 Nov 2024 → 19 Mar 2025
- Decision date (initial)
- 2024-10-18
- 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
Ulcerative colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Faes Farma S.A.
- Sponsor organisation
- Faes Farma S.A.
- Address
- Autonomia Etorbidea 10
- City
- Leioa
- Postcode
- 48940
- Country
- Spain
Scientific contact point
- Organisation
- Faes Farma S.A.
- Contact name
- FAES FARMA Clinical department
Public contact point
- Organisation
- Faes Farma S.A.
- Contact name
- FAES FARMA Clinical department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 34 | 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 |
|---|---|---|---|---|---|
| Spain | 2024-11-28 | 2025-03-19 | 2024-12-03 | 2025-01-23 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Spain | Acceptable 2024-10-03
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-06 | Spain | Acceptable 2025-04-21
|
2025-05-20 |