Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
112
Countries
2
Sites
3
Mild to Moderate Asthma
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 30 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-03
- 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
Mild to Moderate Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 1 |
| Germany | Ongoing, recruiting | 26 | 2 |
| Rest of world
Australia
|
— | 66 | — |
Investigational sites
IKF Pneumologie GmbH & Co. KG
lnstitut fuer klinische Forschung Pneumologie, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Charite Research Organisation GmbH
Medical Operations, Chariteplatz 1, Mitte, Berlin
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 | 2025-09-05 | 2025-09-05 | |||
| Germany | 2025-06-30 | 2025-06-30 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-06 | Belgium | Acceptable 2025-06-02
|
2025-06-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-02 | Belgium | Acceptable | 2025-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-08 | Acceptable | 2025-08-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-19 | Belgium | Acceptable 2025-11-25
|
2025-11-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-12 | Belgium | Acceptable 2025-11-25
|
2026-02-12 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-23 | Belgium | Acceptable 2025-11-25
|
2026-04-23 |