Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Periodontitis
Key facts
- Sponsor
- PerioTrap Pharmaceuticals GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07], Phenomena and Processes [G] - Microbiological Phenomena [G06], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2023-10-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Periodontitis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
PerioTrap Pharmaceuticals GmbH
- Sponsor organisation
- PerioTrap Pharmaceuticals GmbH
- Address
- Weinbergweg 22, Kroellwitz Kroellwitz
- City
- Halle (saale)
- Postcode
- 06120
- Country
- Germany
Scientific contact point
- Organisation
- PerioTrap Pharmaceuticals GmbH
- Contact name
- Mirko Buchholz
Public contact point
- Organisation
- PerioTrap Pharmaceuticals GmbH
- Contact name
- Pierre Tangermann
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-14 | Germany | Acceptable 2023-09-08
|
2023-10-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-18 | Germany | Acceptable | 2023-10-31 |