Overview
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
Status:
Completed
Completed
Trial end date:
2015-01-01
2015-01-01
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Janssen Research & Development, LLCCollaborator:
GlaxoSmithKlineTreatments:
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