Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
48
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03], Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 11 Dec 2025 → ongoing
- Decision date (initial)
- 2025-03-18
- 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
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Address
- Calle De Diego De Leon 62
- City
- Madrid
- Postcode
- 28006
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Gina Paola Mejía Abril
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Gina Paola Mejía Abril
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 48 | 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 | 2025-12-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-06 | Spain | Acceptable 2025-03-18
|
2025-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-15 | Spain | Acceptable 2026-03-23
|
2026-03-30 |