Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
76
Countries
1
Sites
1
Inflammatory Conditions
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
- 23 May 2024 → 3 Jun 2025
- Decision date (initial)
- 2024-05-03
- 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
Inflammatory Conditions
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10021428 | Immune system disorders | 4 |
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 | 76 | 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 | 2024-05-23 | 2025-06-03 | 2024-05-23 | 2025-05-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | Belgium | Acceptable 2024-05-02
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-03 | Belgium | Acceptable 2024-07-18
|
2024-07-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-12 | Belgium | Acceptable | 2024-09-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-15 | Belgium | Acceptable 2024-12-03
|
2024-12-05 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-21 | Belgium | Acceptable 2024-12-03
|
2025-01-21 |