drugset / Trial / NCT01866007

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

NCT01866007

Phase 1 Completed 141 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-05-09
Primary completion
2013-09-20
Completion
2013-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Guselkumab Monoclonal antibody 100 mg Subcutaneous

Indications

No indication recorded.