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

First listed
Oct 7, 2015
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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