Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
50
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524617-84-00
- WHO UTN
- U1111-1330-1841
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy Volunteers
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 |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 50 | 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 |
|---|---|---|---|---|---|
| Germany | 2026-04-09 | 2026-04-09 | 2026-04-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-26 | Germany | Acceptable 2026-03-13
|
2026-03-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-02 | Germany | Acceptable 2026-04-22
|
2026-04-22 |