Clinical trial • Phase I • Other

Izicopan (INF904) for Healthy volunteers

Phase I trial of Izicopan (INF904) for Healthy volunteers. open-label, none/not specified-controlled. 8 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Healthy volunteers
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-03-2026
First CTIS Authorization Date
01-05-2026

Trial design

open-label, none/not specified-controlled Phase I trial in Netherlands.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
8

Eligibility

Recruits 8 No vulnerable populations selected; only male participants are eligible; consent/assent process not specified in the available record..

Vulnerable Population
No vulnerable populations selected; only male participants are eligible; consent/assent process not specified in the available record.

Recruitment

Planned Sample Size
8
Recruitment Window Months
1
Consent Approach
Not specified in the available record.

Geography

Total Number Of Sites
1
Total Number Of Participants
8

Netherlands

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
01-05-2026
Processing Time Days
4
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Pharmaceutical Research Associates Group B.V.
Department Name
Program Management
Contact Person Name
Salah Hadi
Contact Person Email
salah.hadi@iconplc.com
Number Of Participants
8

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
14C-LABELED IZICOPAN (INF904)
Active Substance
Izicopan (INF904)
Modality
Small molecule
Frequency
Single-dose

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