Clinical trial • Phase III • Other

GRT6019

Phase III trial of GRT6019. 24 participants.

Overview

Trial Therapeutic Area
Other
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
09-10-2025
First CTIS Authorization Date
19-12-2025

Trial design

Phase III trial across 1 site in France.

Target Sample Size
24

Eligibility

Recruits 24 No vulnerable population selected; trial includes healthy male participants only; no specific consent or assent handling described..

Vulnerable Population
No vulnerable population selected; trial includes healthy male participants only; no specific consent or assent handling described.

Recruitment

Planned Sample Size
24
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
24

France

Earliest CTIS Part Ii Submission Date
26-11-2025
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
23
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Biotrial
Department Name
Unité Clinique
Contact Person Name
Marina Klein
Contact Person Email
marina.klein@biotrial.com

Sponsor

Primary sponsor

Full Name
Gruenenthal GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
GRT6019

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