Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Tuberculosis
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 1 Jul 2024 → 27 Apr 2026
- Decision date (initial)
- 2024-06-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Tuberculosis
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 |
|---|---|---|---|
| Austria | Ended | 32 | 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 |
|---|---|---|---|---|---|
| Austria | 2024-07-01 | 2026-04-27 | 2024-07-02 | 2025-05-01 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | Austria | Acceptable 2024-06-17
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-20 | Austria | Acceptable | 2024-10-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-25 | Austria | Acceptable | 2024-11-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-20 | Austria | Acceptable | 2025-02-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-24 | Austria | Acceptable | 2025-02-24 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-24 | Austria | Acceptable | 2025-04-24 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-26 | Austria | Acceptable | 2025-07-07 |