Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
1
Not applicable - healthy volunteer trial
Key facts
- Sponsor
- Viatris Innovation GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 17 Nov 2025 → 22 Apr 2026
- Decision date (initial)
- 2025-11-07
- 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
Not applicable - healthy volunteer trial
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Viatris Innovation GmbH
- Sponsor organisation
- Viatris Innovation GmbH
- Address
- Gewerbestrasse 14
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Viatris Innovation GmbH
- Contact name
- EUClinicalTrials@viatris
Public contact point
- Organisation
- Viatris Innovation GmbH
- Contact name
- EUClinicalTrials@viatris
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
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 | 2025-11-17 | 2026-04-22 | 2025-11-20 | 2025-11-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-22 | Netherlands | Acceptable 2025-11-04
|
2025-11-07 |