Clinical trial • Phase III • Other

Clinical trial in Healthy volunteer

Phase III trial for Healthy volunteer. None/Not specified-controlled. 240 participants.

Overview

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

Key dates

Initial CTIS Submission Date
13-08-2024
First CTIS Authorization Date
02-09-2024

Trial design

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

Comparator
None/Not specified
Target Sample Size
240

Eligibility

Recruits 240 Vulnerable population selected; no details on consent or assent handling provided..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided.

Recruitment

Planned Sample Size
240
Recruitment Window Months
179

Geography

Total Number Of Sites
1
Total Number Of Participants
240

Denmark

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
12
Number Of Sites
1
Number Of Participants
240

Sites

Site Name
Rigshospitalet
Department Name
Neurobiology Research Unit
Contact Person Name
Gitte Moos Knudsen
Contact Person Email
gmk@nru.dk

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

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