Clinical trial • Phase I • Infectious Disease

Clinical trial in Healthy volunteers

Phase I trial for Healthy volunteers. 60 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Healthy volunteers
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
29-10-2024
First CTIS Authorization Date
10-12-2024

Trial design

Phase I trial across 1 site in Belgium.

Target Sample Size
60

Recruitment

Planned Sample Size
60
Recruitment Window Months
23

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Belgium

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
09-05-2025
Processing Time Days
161
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Head of Department CEVAC
Principal Investigator Name
Isabel Leroux-Roels
Principal Investigator Email
Isabel.LerouxRoels@UZGent.be
Contact Person Name
Isabel Leroux-Roels
Contact Person Email
Isabel.LerouxRoels@UZGent.be
Number Of Participants
60

Sponsor

Primary sponsor

Full Name
Virometix AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

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