Clinical trial • Phase I • Dermatology

KM-023 for Olmsted syndrome

Phase I trial of KM-023 for Olmsted syndrome. 64 participants.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Olmsted syndrome
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
27-03-2025
First CTIS Authorization Date
25-06-2025

Trial design

Phase I trial in France.

Target Sample Size
64

Recruitment

Planned Sample Size
64
Recruitment Window Months
13

Geography

Total Number Of Sites
2
Total Number Of Participants
64

France

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
323
Number Of Sites
2
Number Of Participants
64

Sites

Site Name
Biotrial
Department Name
Unité Clinique
Contact Person Name
Sophie Hays
Contact Person Email
sophie.hays@biotrial.com
Site Name
Hopital Necker Enfants Malades
Department Name
Service de dermatologie
Contact Person Name
Alain Hovnanian
Contact Person Email
alain.hovnanian@inserm.fr

Sponsor

Primary sponsor

Full Name
Kamari Pharma Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Israel

Investigational products

Investigational Product Name
KM-023
First In Human
Yes

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