Overview

A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

Status:
Completed

Trial end date:
2013-10-09

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Phase:

Phase 1

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Antibodies, Monoclonal