Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
15
Countries
1
Sites
1
Colitis ulcerative
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
- 11 Jun 2025 → 25 Jul 2025
- Decision date (initial)
- 2025-06-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521073-13-00
- WHO UTN
- U1111-1315-4506
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Colitis ulcerative
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
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
- Sanofi-Aventis Recherche & Developpement
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Sanofi-Aventis Recherche & Developpement
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 15 | 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 | 2025-06-11 | 2025-07-25 | 2025-06-13 | 2025-06-13 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-22 | Netherlands | Acceptable 2025-06-04
|
2025-06-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-21 | Netherlands | Acceptable 2025-06-04
|
2025-07-21 |