Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
60
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- Virometix AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2024-12-10
- 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
Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Virometix AG
- Sponsor organisation
- Virometix AG
- Address
- Wagistrasse 14
- City
- Schlieren
- Postcode
- 8952
- Country
- Switzerland
Scientific contact point
- Organisation
- Virometix AG
- Contact name
- Mark Sumeray
Public contact point
- Organisation
- Virometix AG
- Contact name
- Mark Sumeray
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 60 | 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 | 2025-01-29 | 2025-02-13 | 2025-08-05 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-29 | Belgium | Acceptable 2024-12-10
|
2024-12-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-10 | Belgium | Acceptable 2025-03-24
|
2025-03-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-11 | Belgium | Acceptable 2025-05-09
|
2025-05-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Belgium | Acceptable 2025-07-28
|
2025-07-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Belgium | Acceptable 2026-01-19
|
2026-01-19 |