Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
1
Phase I study in healthy male volunteers. Intended indication: prophylaxis of transplant rejection in liver, kidney or heart allograft recipients and for treatment of allograft rejection
Key facts
- Sponsor
- Nucleus Medical GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 23 Mar 2026 → 6 May 2026
- Decision date (initial)
- 2026-03-04
- 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
Phase I study in healthy male volunteers. Intended indication: prophylaxis of transplant rejection in liver, kidney or heart allograft recipients and for treatment of allograft rejection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10048870 | Prophylaxis against transplant rejection | 100000004865 |
| 20.0 | PT | 10023439 | Kidney transplant rejection | 100000004870 |
| 21.1 | LLT | 10050434 | Prophylaxis against liver transplant rejection | 10042613 |
| 21.1 | LLT | 10050432 | Prophylaxis against heart transplant rejection | 10042613 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nucleus Medical GmbH
- Sponsor organisation
- Nucleus Medical GmbH
- Address
- Bavariafilmplatz 7, Geiselgasteig Geiselgasteig
- City
- Gruenwald
- Postcode
- 82031
- Country
- Germany
Scientific contact point
- Organisation
- Nucleus Medical GmbH
- Contact name
- Elke Hortskotte
Public contact point
- Organisation
- Nucleus Medical GmbH
- Contact name
- Wolfgang Beier
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 6 | 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 |
|---|---|---|---|---|---|
| Germany | 2026-03-23 | 2026-05-06 | 2026-03-23 | 2026-03-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-16 | Germany | Acceptable 2026-02-18
|
2026-03-04 |