Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
71
Countries
1
Sites
1
Asthma
Key facts
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 3 Aug 2023 → 15 Dec 2023
- Decision date (initial)
- 2023-07-19
- 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
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chiesi Farmaceutici S.p.A.
- Sponsor organisation
- Chiesi Farmaceutici S.p.A.
- Address
- Via Palermo 26 A
- City
- Parma
- Postcode
- 43122
- Country
- Italy
Scientific contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Public contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 71 | 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 | 2023-08-03 | 2023-12-15 | 2023-09-15 | 2023-12-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-06 | Belgium | Acceptable 2023-07-11
|
2023-07-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | Belgium | Acceptable | 2024-01-15 |