Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
86
Countries
1
Sites
1
Sepsis associated disseminated intravascular coagulation
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 18 Aug 2023 → 29 Jan 2025
- Decision date (initial)
- 2023-07-21
- 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
Sepsis associated disseminated intravascular coagulation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10013442 | Disseminated intravascular coagulation | 100000004851 |
| 20.0 | PT | 10040047 | Sepsis | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 86 | 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 | 2023-08-18 | 2025-01-29 | 2023-08-22 | 2024-11-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-25 | Germany | Acceptable 2023-07-14
|
2023-07-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-11-24 | Germany | Acceptable 2024-01-23
|
2024-01-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-08 | Germany | Acceptable 2024-01-23
|
2024-03-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-09-04 | Germany | Acceptable 2024-09-26
|
2024-09-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-26 | Germany | Acceptable 2025-01-14
|
2025-01-15 |