drugset / Trial / NCT04617691

A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants

NCT04617691

Phase 1 Completed 140 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.

Timeline

Start
2020-11-30
Primary completion
2021-07-20
Completion
2021-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Guselkumab Monoclonal antibody Intravenous

Indications

No indication recorded.