Clinical trial • Phase III • Gastroenterology

duvakitug for Healthy volunteers

Phase III trial of duvakitug for Healthy volunteers. 50 participants.

Overview

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

Key dates

Initial CTIS Submission Date
26-01-2026
First CTIS Authorization Date
17-03-2026

Trial design

Phase III trial across 1 site in Germany.

Target Sample Size
50

Eligibility

Recruits 50 Vulnerable population selected; no details on consent or assent handling available in source..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling available in source.

Recruitment

Planned Sample Size
50
Recruitment Window Months
2

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Germany

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
50
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Klinikum Westend Haus 31, Spandauer Damm 130, Charlottenburg
Department Name
Parexel – Early Phase Clinical Unit Berlin
Contact Person Name
Dirk Palla
Contact Person Email
dirk.palla@parexel.com

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
PAREXEL International GmbH
Responsibilities
Listed as site/operational contact in trialSites (contact and site management)

Investigational products

Investigational Product Name
duvakitug

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