Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
41
Countries
1
Sites
1
Mild allergic asthma
Key facts
- Sponsor
- OM Pharma S.A.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 14 Jun 2024 → 20 Feb 2025
- Decision date (initial)
- 2023-10-17
- 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
Mild allergic asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10001705 | Allergic asthma | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
OM Pharma S.A.
- Sponsor organisation
- OM Pharma S.A.
- Address
- Rue Du Bois-Du-Lan 22
- City
- Meyrin
- Postcode
- 1217
- Country
- Switzerland
Scientific contact point
- Organisation
- OM Pharma S.A.
- Contact name
- Clinical Development Department
Public contact point
- Organisation
- OM Pharma S.A.
- Contact name
- Clinical Development Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 41 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-06-14 | 2025-02-19 | 2024-06-28 | 2025-01-22 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-27 | Germany | Acceptable 2023-10-16
|
2023-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-26 | Germany | Acceptable 2024-04-26
|
2024-06-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-17 | Germany | Acceptable 2024-04-26
|
2024-10-17 |