Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
125
Countries
1
Sites
1
Immuun system diseases
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 19 Jul 2024 → 5 Dec 2024
- Decision date (initial)
- 2024-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511241-19-00
- WHO UTN
- U1111-1301-2757
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immuun system diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 125 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Immunology, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-07-19 | 2024-12-05 | 2024-07-30 | 2024-11-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-10 | Netherlands | Acceptable 2024-07-18
|
2024-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-06 | Netherlands | Acceptable 2024-08-14
|
2024-08-14 |