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Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

NCT02079545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-03-09

No results posted yet for this study

Summary

The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.

Conditions

  • Healthy

Interventions

DRUG

Sirukumab (IV infusion)

Participants will receive a single IV infusion of 100 mg sirukumab.

DRUG

Sirukumab (SC injection with PFS-U)

Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.

DRUG

Sirukumab (SC injection with PFS-AI)

Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.

DRUG

Sirukumab (SC injection with PFS-U)

Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.

DRUG

Sirukumab (SC injection with PFS-AI)

Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02079545 on ClinicalTrials.gov