Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Immunological/cardiovascular conditions
Key facts
- Sponsor
- Centre for Human Drug Research
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 28 May 2024 → 6 Feb 2025
- Decision date (initial)
- 2024-05-23
- 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
Immunological/cardiovascular conditions
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre for Human Drug Research
- Sponsor organisation
- Centre for Human Drug Research
- Address
- Zernikedreef 8
- City
- Leiden
- Postcode
- 2333 CL
- Country
- Netherlands
Scientific contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Geert Jan Groeneveld
Public contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Geert Jan Groeneveld
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Immunology, Zernikedreef 8, 2333 CL, Leiden
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 | 2024-05-28 | 2025-02-06 | 2024-06-03 | 2025-02-06 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Netherlands | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-27 | Netherlands | Acceptable 2024-05-23
|
2024-05-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-03 | Netherlands | Acceptable 2024-07-22
|
2024-07-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-30 | Netherlands | Acceptable 2024-07-22
|
2024-08-30 |