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
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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