Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Community-acquired bacterial pneumonia
Key facts
- Sponsor
- Basilea Pharmaceutica International AG Allschwil
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 17 Jan 2025 → 25 Feb 2025
- Decision date (initial)
- 2024-12-24
- 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
Community-acquired bacterial pneumonia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10035664 | Pneumonia | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Basilea Pharmaceutica International AG Allschwil
- Sponsor organisation
- Basilea Pharmaceutica International AG Allschwil
- Address
- Hegenheimermattweg 167b
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-01-17 | 2025-02-25 | 2025-01-17 | 2025-01-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-04 | Netherlands | Acceptable 2024-12-24
|
2024-12-24 |