Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
88
Countries
1
Sites
1
Inflammatory bowel diseases and psoriasis.
Key facts
- Sponsor
- Coultreon Biopharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 28 Aug 2025 → ongoing
- Decision date (initial)
- 2025-08-13
- 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
Inflammatory bowel diseases and psoriasis.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10021972 | Inflammatory bowel disease | 100000004856 |
| 20.0 | PT | 10037153 | Psoriasis | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Coultreon Biopharma
- Sponsor organisation
- Coultreon Biopharma
- Address
- Gaston Geenslaan 3
- City
- Leuven
- Postcode
- 3001
- Country
- Belgium
Scientific contact point
- Organisation
- ONCO3R Therapeutics
- Contact name
- Magdalena Petkova
Public contact point
- Organisation
- ONCO3R Therapeutics
- Contact name
- Magdalena Petkova
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 88 | 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 | 2025-08-28 | 2025-08-28 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-01 | Belgium | Acceptable 2025-08-08
|
2025-08-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-26 | Belgium | Acceptable 2025-08-08
|
2025-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-08 | Belgium | Acceptable 2026-01-26
|
2026-01-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-10 | Belgium | Acceptable 2026-02-23
|
2026-02-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-06 | Belgium | Acceptable 2026-02-23
|
2026-05-06 |