A Phase 1, Open-Label, Single-Dose Mass Balance and Metabolite Profiling Study of 14C-LABELED Izicopan (INF904) in Healthy Male Participants

2026-525517-31-00 Protocol INF904-P1.2 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 4 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol INF904-P1.2

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 8
Countries 1
Sites 1

Not applicable, healthy volunteers

Key facts

Sponsor
InflaRx GmbH
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male
Therapeutic area
Not possible to specify
Trial duration
4 May 2026 → ongoing
Decision date (initial)
2026-05-01
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Not applicable, healthy volunteers

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

InflaRx GmbH

Sponsor organisation
InflaRx GmbH
Address
Winzerlaer Strasse 2, Ammerbach Ammerbach
City
Jena
Postcode
07745
Country
Germany

Scientific contact point

Organisation
InflaRx GmbH
Contact name
Chief Medical Officer

Public contact point

Organisation
InflaRx GmbH
Contact name
Chief Medical Officer

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 8 1
Rest of world 0

Investigational sites

Netherlands

1 site · Ongoing, recruiting
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2026-05-04 2026-05-08

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-06 Netherlands Acceptable
2026-05-01
2026-05-01