Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
234
Countries
1
Sites
1
Immune system diseases
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement, 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
- 12 Jun 2023 → 7 Aug 2024
- Decision date (initial)
- 2023-06-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502923-23-00
- WHO UTN
- U1111-1280-7324
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immune system diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10076055 | Clinical trial participant | 100000004869 |
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 Research & Development
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
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 Research & Development
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 234 | 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 |
|---|---|---|---|---|---|
| Belgium | 2023-06-12 | 2024-08-07 | 2023-06-12 | 2024-05-21 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-11 | Belgium | Acceptable with conditions 2023-06-06
|
2023-06-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-06-20 | Belgium | Acceptable 2023-07-04
|
2023-07-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-06 | Belgium | Acceptable 2023-07-04
|
2023-09-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-08 | Belgium | Acceptable 2024-03-27
|
2024-03-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-14 | Belgium | 2024-05-14 |