Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
50
Countries
1
Sites
1
Pseudomonas colonization
Key facts
- Sponsor
- Charite Research Organisation GmbH
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 21 Aug 2023 → 27 May 2025
- Decision date (initial)
- 2023-08-08
- 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
Pseudomonas colonization
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10068292 | Pseudomonas colonization | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Charite Research Organisation GmbH
- Sponsor organisation
- Charite Research Organisation GmbH
- Address
- Chariteplatz 1, Mitte Mitte
- City
- Berlin
- Postcode
- 10117
- Country
- Germany
Scientific contact point
- Organisation
- Charite Research Organisation GmbH
- Contact name
- Scientific Service
Public contact point
- Organisation
- Charite Research Organisation GmbH
- Contact name
- Public enquiries
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | 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 | 2023-08-21 | 2025-05-27 | 2023-08-21 | 2025-05-27 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-21 | Germany | Acceptable 2023-08-08
|
2023-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-21 | Germany | Acceptable 2024-02-21
|
2024-03-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-24 | Germany | Acceptable 2024-08-12
|
2024-08-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-05 | Germany | Acceptable 2024-10-16
|
2024-10-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-12-18 | Germany | Acceptable 2024-10-16
|
2024-12-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-03 | Germany | Acceptable 2025-02-19
|
2025-02-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-27 | Germany | Acceptable 2025-02-19
|
2025-05-27 |