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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04147338
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 subcutaneously.

Study Details

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

Key Dates

Start date
Oct 30, 2019
Status verified
Jan 2025
Primary completion
Sep 13, 2021
Completion
Dec 7, 2021

Study Design

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

Arms

  • Experimental: Reference Device: Guselkumab
    Participants will receive subcutaneous (SC) injections of guselkumab in reference device.
  • Experimental: Test Device 1: Guselkumab
    Participants will receive SC injections of guselkumab in test device 1.
  • Experimental: Test Device 2: Guselkumab
    Participants will receive SC injections of guselkumab in test device 2.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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