Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
32
Countries
1
Sites
1
Pseudomonas colonization
Key facts
- Sponsor
- Charite Research Organisation GmbH
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2023-07-07
- 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 | Not authorised | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-30 | Germany | Not acceptable 2023-06-19
|
2023-07-07 |