Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
105
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 4 Jan 2024 → 14 Jan 2025
- Decision date (initial)
- 2023-11-17
- 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
Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 105 | 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 | 2024-01-04 | 2024-01-04 | 2025-01-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-12 | Belgium | Acceptable 2023-11-16
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-24 | Belgium | Acceptable | 2023-12-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-08 | Belgium | Acceptable 2024-02-23
|
2024-03-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-04 | Belgium | Acceptable 2024-10-11
|
2024-10-16 |