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A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

NCT01866007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-01-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System \[PFS-U\] or with a prefilled syringe facilitated injection device \[PFS FID\]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Guselkumab (lyophilized formulation)

Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.

DRUG

Guselkumab (liquid formulation with PFS-U)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.

DRUG

Guselkumab (liquid formulation with PFS FID)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.

DRUG

Guselkumab (liquid formulation)

Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-09
Primary Completion
2013-09-20
Completion
2013-10-09
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 NCT01866007 on ClinicalTrials.gov