Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Fibrostenotic Crohn’s disease
Key facts
- Sponsor
- Agomab Spain S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 30 Jan 2024 → 13 May 2024
- Decision date (initial)
- 2023-07-25
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Agomab Spain S.L.
- Sponsor organisation
- Agomab Spain S.L.
- Address
- Poligono Parque Empresarial Parcelas 26-27, Fonte Diaz Fonte Diaz
- City
- Touro
- Postcode
- 15822
- Country
- Spain
Scientific contact point
- Organisation
- Agomab Spain S.L.
- Contact name
- Tim Van Kaem
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 | 24 | 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 | 2024-01-30 | 2024-05-13 | 2024-03-12 | 2024-05-06 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-15 | Belgium | Acceptable 2023-07-24
|
2023-07-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-12 | Belgium | Acceptable 2024-01-31
|
2024-02-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-23 | Belgium | Acceptable 2024-03-12
|
2024-03-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-19 | Belgium | Acceptable 2024-04-04
|
2024-04-04 |