A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels)
 comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL)
 liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6
 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.
This is a multicenter (when more than one hospital or medical school team work on a medical
 research study), randomized (study drug is assigned by chance), parallel (a clinical trial
 comparing the response in two or more groups of participants receiving different treatments),
 open-label (all people know the identity of the intervention) single-dose,
 inpatient/outpatient study in healthy participants. The study consists of following periods:
 Screening (within 28 days before study drug administration), inpatient period (Day 1 to 4)
 and outpatient period (up to Day 141). Eligible participants will be randomly assigned in a
 1:1 ratio to either 1 of 2 treatment groups (that is, Ustekinumab 90 mg/mL or Ustekinumab 5
 mg/mL) and will receive treatment on Day 1. The PK comparability of 2 different formulations
 of ustekinumab, diluted in saline, will be evaluated primarily. Participants' safety will be
 monitored throughout the study.
Inclusion Criteria:

 -  Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive and a body mass
 index (BMI) of 18.5 kilogram per square meter (kg/m^2) to 29.0 kg/m^2, inclusive

 -  If a woman, she must be incapable of pregnancy or using a highly effective method of
 birth control

 -  A woman must have a negative serum pregnancy test

 -  A man who is sexually active with a woman of childbearing potential and has not had a
 vasectomy must agree to use a barrier method of birth control

 -  Participant must be willing and able to adhere to the prohibitions and restrictions
 specified in this protocol

 -  Are nonsmokers or agree to smoke no more than 10 cigarettes or 2 cigars per day
 throughout the study

 Exclusion Criteria:

 -  Participant currently has or has a history of any clinically significant medical
 illness or medical disorders including malignancy

 -  Participant has previously received ustekinumab

 -  Participant has a known or suspected intolerance or hypersensitivity to any biologic
 medication including ustekinumab

 -  Participant has received an investigational drug within a specified period prior to
 the planned first dose of study drug or is currently enrolled in an investigational
 study