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

NCT02570373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-25
Primary Completion
2016-01-12
Completion
2016-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570373 on ClinicalTrials.gov