Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
48
Countries
1
Sites
1
Inflammatory Gastrointestinal Disease
Key facts
- Sponsor
- Ferring Pharmaceuticals A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 20 Feb 2024 → 15 Nov 2024
- Decision date (initial)
- 2024-02-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507882-24-00
- WHO UTN
- U1111-1297-2280
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Inflammatory Gastrointestinal Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10017969 | Gastrointestinal inflammatory conditions | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ferring Pharmaceuticals A/S
- Sponsor organisation
- Ferring Pharmaceuticals A/S
- Address
- Amager Strandvej 405
- City
- Kastrup
- Postcode
- 2770
- Country
- Denmark
Scientific contact point
- Organisation
- Ferring Pharmaceuticals A/S
- Contact name
- Arjun Ravi
Public contact point
- Organisation
- Ferring Pharmaceuticals A/S
- Contact name
- Clinical and Translational Sciences
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 48 | 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 | 2024-02-20 | 2024-11-15 | 2024-03-05 | 2024-11-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-02 | Germany | Acceptable 2024-02-02
|
2024-02-08 |