Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Pharmacokinetic study in healthy volunteers under fasted conditions.
Key facts
- Sponsor
- Faes Farma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 6 Oct 2025 → 19 Nov 2025
- Decision date (initial)
- 2025-09-08
- 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
Pharmacokinetic study in healthy volunteers under fasted conditions.
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 |
|---|---|---|---|
| Czechia | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Czechia | 2025-10-06 | 2025-11-19 | 2025-10-06 | 2025-10-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-07 | Czechia | Acceptable 2025-09-08
|
2025-09-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-12 | Czechia | Acceptable 2025-09-08
|
2025-09-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-08 | Czechia | Acceptable 2025-09-08
|
2025-10-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-15 | Czechia | Acceptable 2025-09-08
|
2025-12-15 |