Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Must have a weight in the range of 50.0 kg to 100.0 kg, inclusive

• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram performed at screening

• Each participant must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study

• Must be willing and able to adhere to the study visit schedule and other protocol requirements

• Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study

Exclusion Criteria:

• Have any known malignancy or history of malignancy, except for nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1

• Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly

• Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study

• Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)

• Have a history of or current elevations in triglycerides that required treatment