Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
60
Countries
1
Sites
1
Pneumonia
Key facts
- Sponsor
- Institut National De La Sante Et De La Recherche Medicale
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 14 Apr 2025 → 17 Apr 2026
- Decision date (initial)
- 2024-10-24
- 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
Pneumonia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut National De La Sante Et De La Recherche Medicale
- Sponsor organisation
- Institut National De La Sante Et De La Recherche Medicale
- Address
- 101 Rue De Tolbiac
- City
- Paris Cedex 13
- Postcode
- 75654
- Country
- France
Scientific contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Antoine Guillon
Public contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Antoine Guillon
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 Regional Universitaire De Tours
Intensive Care Medicine Department, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
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 | 2025-04-14 | 2026-04-17 | 2025-04-14 | 2026-03-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | France | Acceptable with conditions 2024-10-24
|
2024-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | France | Acceptable with conditions | 2025-03-20 |