Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
12
Countries
1
Sites
1
modulation of the innate immune system in healthy subjects
Key facts
- Sponsor
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Microbiological Phenomena [G06], Diseases [C] - Virus Diseases [C02], Phenomena and Processes [G] - Immune system processes [G12], Phenomena and Processes [G] - Immune System Phenomena [G13]
- Trial duration
- 20 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-08
- 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
modulation of the innate immune system in healthy subjects
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Sponsor organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Address
- Venusberg-Campus 1, Venusberg Venusberg
- City
- Bonn
- Postcode
- 53127
- Country
- Germany
Scientific contact point
- Organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Contact name
- Prof. Dr. rer. nat. Rayk Behrendt
Public contact point
- Organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Contact name
- Prof. Dr. rer. nat. Rayk Behrendt
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 12 | 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 | 2024-06-20 | 2024-06-21 | 2024-10-21 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Germany | Acceptable 2024-04-22
|
2024-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-16 |