Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
3
critical limb ischemia
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 11 Feb 2026 → ongoing
- Decision date (initial)
- 2024-10-07
- 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
critical limb ischemia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- Amandine PAUZE
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- Amandine PAUZE
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Service de médecine vasculaire, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Service de chirurgie vasculaire et médecine vasculaire, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Bordeaux
Service de médecine interne et vasculaire, 1 Rue Jean Burguet, 33000, Bordeaux
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 |
|---|---|---|---|---|---|
| France | 2026-02-11 | 2026-02-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | France | Acceptable 2024-10-04
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-06 | France | Acceptable 2025-12-03
|
2025-12-04 |