NCT04147338

A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Guselkumab	Guselkumab will be administered subcutaneously.

Timeline

• Start date: 2019-10-30
• Primary completion: 2021-09-13
• Completion: 2021-12-07
• First posted: 2019-11-01
• Last updated: 2025-02-03

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study