Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
60
Countries
1
Sites
1
Nipah Virus
Key facts
- Sponsor
- Teikyo University
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2026-03-09
- 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
Nipah Virus
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teikyo University
- Sponsor organisation
- Teikyo University
- Address
- 2-11-1 Kaga
- City
- Itabashi
- Postcode
- 173-8605
- Country
- Japan
Scientific contact point
- Organisation
- Teikyo University
- Contact name
- Misako Yoneda
Public contact point
- Organisation
- Teikyo University
- Contact name
- Misako Yoneda
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 60 | 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 | 2026-01-16 | Belgium | Acceptable with conditions 2026-03-09
|
2026-03-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-16 | Belgium | Acceptable 2026-04-07
|
2026-04-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-09 | Belgium | Acceptable 2026-04-16
|
2026-04-16 |