Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
30
Countries
2
Sites
2
Chronic hepatitis B infection
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-04-10
- 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
Chronic hepatitis B infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Department of Infectious Diseases
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Department of Infectious Diseases
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 15 | 1 |
| Germany | Not authorised | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Region Midtjylland
Dept. of Infectious Diseases, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-13 | Denmark | Not acceptable 2024-04-09
|
2024-04-10 |