Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Bioequivalence study
Status
Ended
Participants planned
13
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 1 Mar 2024 → 15 May 2024
- Decision date (initial)
- 2024-02-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508030-33-00
- WHO UTN
- U1111-1291-2123
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 1 Avenue Pierre Brossolette
- City
- Chilly Mazarin
- Postcode
- 91380
- 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 | 13 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2024-03-01 | 2024-03-01 | 2024-03-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-09 | Netherlands | Acceptable 2024-02-27
|
2024-02-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-29 | Netherlands | Acceptable 2024-05-10
|
2024-05-10 |