Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
40
Countries
1
Sites
1
Healthy participants
Key facts
- Sponsor
- TNO Netherlands Organisation for applied scientific research
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 31 Mar 2025
- Decision date (initial)
- 2024-08-26
- 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
Healthy participants
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
TNO Netherlands Organisation for applied scientific research
- Sponsor organisation
- TNO Netherlands Organisation for applied scientific research
- Address
- Kampweg 55
- City
- Soesterberg
- Postcode
- 3769 DE
- Country
- Netherlands
Scientific contact point
- Organisation
- TNO Netherlands Organisation for applied scientific research
- Contact name
- TNO desk location Soesterberg
Public contact point
- Organisation
- TNO Netherlands Organisation for applied scientific research
- Contact name
- TNO desk location Soesterberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
TNO Netherlands Organisation for applied scientific research
Human Performance, Kampweg 55, 3769 DE, Soesterberg
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Netherlands | Acceptable with conditions 2024-08-19
|
2024-08-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-15 | Netherlands | Acceptable 2024-11-12
|
2024-11-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Netherlands | Acceptable 2025-03-14
|
2025-03-14 |