Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Hard-to-heal-wounds
Key facts
- Sponsor
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 10 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-22
- 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
Hard-to-heal-wounds
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10048036 | Wound healing delayed | 10018065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Sponsor organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Address
- Avenida De Roma Sn
- City
- Oviedo
- Postcode
- 33011
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Contact name
- Silvia Perez Lopez
Public contact point
- Organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Contact name
- Faustino Blanco
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 10 | 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 | 2024-06-10 | 2024-06-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-04 | Spain | Acceptable 2024-03-22
|
2024-03-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-10 | Spain | Acceptable 2025-05-08
|
2025-05-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-13 | Spain | Acceptable 2026-05-27
|
2026-06-01 |