Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
128
Countries
1
Sites
1
Asthma
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 6 May 2024 → 24 Dec 2024
- Decision date (initial)
- 2024-04-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509316-28-00
- WHO UTN
- U1111-1300-4371
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
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 |
|---|---|---|---|
| Belgium | Ended | 128 | 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 | 2024-05-06 | 2024-12-24 | 2024-05-06 | 2024-08-27 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-29 | Belgium | Acceptable 2024-04-10
|
2024-04-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-26 | Belgium | Acceptable 2024-04-10
|
2024-04-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-19 | Belgium | Acceptable 2024-04-10
|
2024-06-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-19 | Belgium | Acceptable 2024-08-06
|
2024-08-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-26 | Belgium | Acceptable 2024-08-06
|
2024-08-26 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-07 | Belgium | Acceptable 2024-08-06
|
2025-01-07 |