Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

This is a randomized (the study medication is assigned by chance), open-label (all people
know the identity of the intervention), parallel-group (each group of participants will be
treated at the same time), multicenter; single-dose study. Approximately 138 participants
will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows:
Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous
[SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg
sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and
Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be
stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg).
Participants will be hospitalized in the study unit for administration of study drug and
will be discharged after completion of all scheduled assessments on Day 5. Participants will
be required to return to the study unit for outpatient visits on Days 6 and 7, followed by
weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after
study drug administration. Safety evaluations will include assessment of adverse events,
physical examination, vital signs, injection site and infusion reactions, electrocardiogram,
and clinical laboratory tests. The maximum study duration for each participant will be 120
days.

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