Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Healthy volunteer
Key facts
- Sponsor
- DeuterOncology
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 12 Dec 2024 → 8 Jul 2025
- Decision date (initial)
- 2024-11-25
- 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 volunteer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
DeuterOncology
- Sponsor organisation
- DeuterOncology
- Address
- Clos Chanmurly 13
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- DeuterOncology
- Contact name
- Timothy Perera
Public contact point
- Organisation
- DeuterOncology
- Contact name
- Timothy Perera
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
PreCare Trial & Recruitment B.V.
PT&R, Kasteelhof 5, 6121 XK, Born
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 | 2024-12-12 | 2025-07-08 | 2025-01-06 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Netherlands | Acceptable 2024-11-25
|
2024-11-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-25 | Netherlands | Acceptable 2025-05-19
|
2025-05-19 |