Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
1
Respiratory tract diseases
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517939-53-00
- EudraCT number
- 2023-000175-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Respiratory tract diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- L.C. Steinbusch
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- L.C. Steinbusch
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Leiden University Medical Center
Pulmonology, Albinusdreef 2, 2333 ZA, Leiden
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Netherlands | Acceptable 2024-11-15
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-17 | Netherlands | Acceptable 2025-07-09
|
2025-07-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-10 | Netherlands | Acceptable 2025-07-09
|
2025-08-10 |