Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Fibrostenotic Crohn’s disease
Key facts
- Sponsor
- Agomab Spain S.L.U.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 18 Jul 2025 → 15 Sep 2025
- Decision date (initial)
- 2025-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Fibrostenotic Crohn’s disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086076 | Fibrostenotic Crohn´s disease | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Agomab Spain S.L.U.
- Sponsor organisation
- Agomab Spain S.L.U.
- Address
- Parque Empresarial De Touro Parcelas 26-27, Fonte Diaz Fonte Diaz
- City
- A Coruna
- Postcode
- 15822
- Country
- Spain
Scientific contact point
- Organisation
- Agomab Spain S.L.
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Agomab Spain S.L.
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 40 | 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 | 2025-07-18 | 2025-09-15 | 2025-07-18 | 2025-09-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-16 | Belgium | Acceptable 2025-06-26
|
2025-06-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-17 | Belgium | Acceptable 2025-06-26
|
2025-09-17 |