Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
Herpes simplex virus encephalitis
Key facts
- Sponsor
- Fuics Development Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2025-11-18
- 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
Herpes simplex virus encephalitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10019953 | Herpes simplex encephalitis | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fuics Development Limited
- Sponsor organisation
- Fuics Development Limited
- Address
- Leontiou Machaira 58
- City
- Limassol
- Postcode
- 3025
- Country
- Cyprus
Scientific contact point
- Organisation
- Fuics Development Limited
- Contact name
- Company management
Public contact point
- Organisation
- Fuics Development Limited
- Contact name
- Company management
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-05 | Bulgaria | Acceptable 2025-11-17
|
2025-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-09 | Bulgaria | Acceptable 2026-01-27
|
2026-01-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-09 | Bulgaria | Acceptable 2026-05-15
|
2026-05-18 |