A study to evaluate the safety and tolerability of JNJ-90106848 and to investigate how long JNJ-90106848 stays in and acts on the body (pharmacokinetics) and how the body responds to JNJ-90106848 (pharmacodynamics) when injected into healthy volunteer participants

Start 21 Aug 2025 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol 90106848EDI1001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruitment ended

Participants planned 63

Countries 1

Sites 1

Inflammatory Conditions

Key facts

Sponsor: Janssen Cilag International
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trial duration: 21 Aug 2025 → ongoing
Decision date (initial): 2025-08-11
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

Inflammatory Conditions

Version	Level	Code	Term	System organ class
28.0	SOC	10021428	Immune system disorders	4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation: Janssen Cilag International
Address: Turnhoutseweg 30
City: Beerse
Postcode: 2340
Country: Belgium

Scientific contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Public contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruitment ended	63	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ongoing, recruitment ended

SGS Belgium

SGS Clinical Pharmacology Unit, Drie Eikenstraat 655, 2650, Edegem

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2025-08-21		2025-08-21	2026-04-10

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-02	Belgium	Acceptable with conditions 2025-08-04	2025-08-11
2	SUBSTANTIAL MODIFICATION	SM-1	2025-09-23	Belgium	Acceptable with conditions	2025-10-10
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-02-11	Belgium	Acceptable with conditions	2026-02-11