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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04617691
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as IV solution derived from FVP or PFS-U.

Study Details

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.

Key Dates

Start date
Nov 30, 2020
Status verified
Aug 2021
Primary completion
Jul 20, 2021
Completion
Jul 20, 2021

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1: Guselkumab PFS-U
    Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.
  • Experimental: Group 2: Guselkumab FVP
    Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: Up to Day 85 ]

Related Studies