Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
52
Countries
1
Sites
1
Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 10 Jul 2024 → ongoing
- Decision date (initial)
- 2024-03-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tübingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Sebastian Volc
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Sebastian Volc
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 52 | 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 | 2024-07-10 | 2024-08-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Germany | Acceptable 2024-03-28
|
2024-03-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-15 | Germany | Acceptable 2024-03-28
|
2024-05-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-01 | Germany | Acceptable 2024-03-28
|
2025-10-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-30 | Germany | Acceptable 2025-11-28
|
2025-12-03 |