Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
25
Countries
1
Sites
1
Not applicable; this trial investigates a physiological process in healthy volunteers.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 4 Mar 2025 → 21 Apr 2026
- Decision date (initial)
- 2025-02-26
- 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
Not applicable; this trial investigates a physiological process in healthy volunteers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Heleen Marynissen
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Heleen Marynissen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 25 | 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 |
|---|---|---|---|---|---|
| Belgium | 2025-03-04 | 2026-04-21 | 2025-03-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-23 | Belgium | Acceptable 2025-02-25
|
2025-02-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-03 | Belgium | Acceptable 2025-02-25
|
2026-04-03 |