Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
24
Countries
1
Sites
1
Circulatory shock
Key facts
- Sponsor
- 4TEEN4 Pharmaceuticals GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 11 Mar 2024 → 5 Jul 2024
- Decision date (initial)
- 2024-02-21
- 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
Circulatory shock
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
4TEEN4 Pharmaceuticals GmbH
- Sponsor organisation
- 4TEEN4 Pharmaceuticals GmbH
- Address
- Neuendorfstrasse 15 A
- City
- Hennigsdorf
- Postcode
- 16761
- Country
- Germany
Scientific contact point
- Organisation
- 4TEEN4 Pharmaceuticals GmbH
- Contact name
- Karine Bourgeois
Public contact point
- Organisation
- 4TEEN4 Pharmaceuticals GmbH
- Contact name
- Karine Bourgeois
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum / RADBOUDUMC
Intensive Care, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-03-11 | 2024-07-05 | 2024-03-11 | 2024-06-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | Netherlands | Acceptable 2024-02-21
|
2024-02-21 |