Clinical trial • Phase III • Other

Clinical trial in Healthy volunteers

Phase III trial for Healthy volunteers. None/Not specified-controlled. 16 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Healthy volunteers
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
17-10-2024
First CTIS Authorization Date
11-12-2024

Trial design

None/Not specified-controlled Phase III trial across 1 site in Austria.

Comparator
None/Not specified
Target Sample Size
16

Eligibility

Recruits 16 Vulnerable populations not selected; no assent/consent handling described.

Vulnerable Population
Vulnerable populations not selected; no assent/consent handling described

Recruitment

Planned Sample Size
16
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Austria

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
44
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Clinical Pharmacology
Contact Person Name
Bernd Jilma
Contact Person Email
bernd.jilma@meduniwien.ac.at
Number Of Participants
16

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

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