A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Ustekinumab

Criteria

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