Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
1
healthy volunteer
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- completed 30 Oct 2025
- Decision date (initial)
- 2024-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516309-21-00
- EudraCT number
- 2020-006105-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
healthy volunteer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- 25 Boulevard Pasteur
- City
- Saint-Etienne
- Postcode
- 42100
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- project manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- project manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Saint Etienne
Département Infectiologie, 25 Boulevard Pasteur, 42100, Saint-Etienne
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | France | Acceptable 2024-08-29
|
2024-08-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-16 | France | Acceptable 2024-11-22
|
2024-11-22 |