Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Allergic reactions (Type 1), including anaphylaxis, idiopathic anaphylaxis or exercise-induced anaphylaxis
Key facts
- Sponsor
- Mylan Pharmaceuticals Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 10 Jan 2025 → 17 May 2025
- Decision date (initial)
- 2024-12-05
- 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
Allergic reactions (Type 1), including anaphylaxis, idiopathic anaphylaxis or exercise-induced anaphylaxis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10001718 | Allergic reaction | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mylan Pharmaceuticals Inc.
- Sponsor organisation
- Mylan Pharmaceuticals Inc.
- Address
- 3711 Collins Ferry Road
- City
- Morgantown
- Postcode
- 26505-2362
- Country
- United States
Scientific contact point
- Organisation
- Mylan Pharmaceuticals Inc.
- Contact name
- EUClinicalTrials@viatris
Public contact point
- Organisation
- Mylan Pharmaceuticals Inc.
- Contact name
- EUClinicalTrials@viatris
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 12 | 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 | 2025-01-10 | 2025-05-16 | 2025-01-10 | 2025-05-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Germany | Acceptable 2024-12-04
|
2024-12-05 |