Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
40
Countries
1
Sites
1
Antidote
Key facts
- Sponsor
- Direction Centrale Du Service De Sante Des Armees
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Disorders of Environmental Origin [C21]
- Trial duration
- 18 Jan 2024 → 16 Dec 2024
- Decision date (initial)
- 2024-01-02
- 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
Antidote
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Direction Centrale Du Service De Sante Des Armees
- Sponsor organisation
- Direction Centrale Du Service De Sante Des Armees
- Address
- 1 Place Alphonse Laveran
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Direction Centrale Du Service De Sante Des Armees
- Contact name
- Chef de bureau
Public contact point
- Organisation
- Direction Centrale Du Service De Sante Des Armees
- Contact name
- Chef de bureau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 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 |
|---|---|---|---|---|---|
| France | 2024-01-18 | 2024-12-16 | 2024-01-18 | 2024-10-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-06 | France | Acceptable 2024-01-02
|
2024-01-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-02 | France | Acceptable 2024-03-18
|
2024-03-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-17 | France | Acceptable 2024-03-18
|
2024-05-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-17 | France | Acceptable 2024-07-05
|
2024-07-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-19 | France | Acceptable 2024-07-30
|
2024-07-30 |