A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02570373
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Guselkumab — DRUG
    Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1.

Study Details

The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.

Key Dates

Start date
Sep 25, 2015
Status verified
Jan 2025
Primary completion
Jan 12, 2016
Completion
Jan 12, 2016

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Guselkumab
    Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1.

Primary Outcome Measure

Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants [ Time Frame: Up to 43 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
-TempeArizona--

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