Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
30
Countries
1
Sites
1
Influenza prophylaxis
Key facts
- Sponsor
- Oslo University Hospital Hf
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 11 Sep 2023 → ongoing
- Decision date (initial)
- 2023-06-26
- 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
Influenza prophylaxis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital Hf
- Sponsor organisation
- Oslo University Hospital Hf
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Gunnveig Grødeland
Public contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Gunnveig Grødeland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 30 | 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 |
|---|---|---|---|---|---|
| Norway | 2023-09-11 | 2023-09-11 | 2025-10-17 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-28 | Norway | Acceptable 2023-06-19
|
2023-06-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-04 | Norway | Acceptable 2023-07-19
|
2023-07-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-24 | Norway | Acceptable | 2023-09-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-13 | Norway | Acceptable 2023-06-19
|
2023-09-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-17 | Norway | Acceptable 2023-11-30
|
2023-11-30 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-30 | Norway | 2023-11-30 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-06 | Norway | Acceptable 2024-09-30
|
2024-09-30 |