Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Countries
1
Sites
1
Immune Aging, Chronic inflammation
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Phenomena and Processes [G] - Immune system processes [G12]
- Decision date (initial)
- 2026-06-08
- 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
Immune Aging, Chronic inflammation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | SOC | 10021428 | Immune system disorders | 4 |
| 20.0 | LLT | 10013229 | Disorder immune system (NOS) | 10021428 |
| 20.0 | PT | 10021425 | Immune system disorder | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Dr. Jaap ten Oever
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Dr. Jaap ten Oever
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | 0 | 1 | |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-19 | Netherlands | Acceptable 2026-06-08
|
2026-06-08 |