Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
15
Countries
1
Sites
1
Crimean Congo Hemorrhagic Fever
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 25 Sep 2024 → 17 Mar 2026
- Decision date (initial)
- 2024-05-03
- 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
Crimean Congo Hemorrhagic Fever
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10010685 | Congo-Crimean haemorrhagic fever | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Alfred Nobels Alle 8, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 52
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Matti Sällberg
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Matti Sällberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 15 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-09-25 | 2026-03-17 | 2024-11-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-07 | Sweden | Acceptable with conditions 2024-05-02
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-07 | Sweden | Acceptable 2024-08-05
|
2024-08-06 |