Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
48
Countries
1
Sites
1
Treatment and post exposure prevention of respiratory tract infection
Key facts
- Sponsor
- Softox Defense Solutions AS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 11 May 2026 → ongoing
- Decision date (initial)
- 2026-02-20
- 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
Treatment and post exposure prevention of respiratory tract infection
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Softox Defense Solutions AS
- Sponsor organisation
- Softox Defense Solutions AS
- Address
- Martin Linges Vei 25
- City
- Fornebu
- Postcode
- 1364
- Country
- Norway
Scientific contact point
- Organisation
- Softox Defense Solutions AS
- Contact name
- CEO/CSO
Public contact point
- Organisation
- Softox Defense Solutions AS
- Contact name
- CEO/CSO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Authorised, recruiting | 48 | 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 |
|---|---|---|---|---|---|
| Ireland | 2026-05-11 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | Ireland | Acceptable 2026-02-06
|
2026-02-20 |