Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Healthy
Key facts
- Sponsor
- Hvidovre Hospital
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune System Phenomena [G13], Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2024-03-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506284-34-00
- ClinicalTrials.gov
- NCT06431932
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hvidovre Hospital
- Sponsor organisation
- Hvidovre Hospital
- Address
- Kettegaard Alle 30
- City
- Hvidovre
- Postcode
- 2650
- Country
- Denmark
Scientific contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Principal investigator Ove Andersen
Public contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Project coordinator Line Rasmussen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 60 | 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 |
|---|---|---|---|---|---|
| Denmark | 2026-03-24 | 2026-03-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Denmark | Acceptable 2024-03-22
|
2024-03-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-21 | Denmark | Not acceptable 2025-03-05
|
2025-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-27 | Denmark | Acceptable 2025-07-04
|
2025-07-04 |