Clinical trial • Phase I • Infectious Disease
Clinical trial in Chronic hepatitis B
Phase I trial for Chronic hepatitis B. 30 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B
- Trial Stage
- Phase I
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 13-12-2023
- First CTIS Authorization Date
- 10-04-2024
Trial design
Phase I trial across 2 sites in Denmark, Germany.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 30
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 30
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Region Midtjylland
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Ole Schmeltz Søgaard
- Contact Person Email
- olesoega@rm.dk
- Number Of Participants
- 15
Germany
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Infectious Diseases and Critical Care Medicine
- Contact Person Name
- Christian Gaebler
- Contact Person Email
- infektiologie-pneumologie@charite.de
- Number Of Participants
- 15
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
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