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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ustekinumab

• Registration Number: NCT02156375
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ustekinumab 90 mg/mL	Ustekinumab	-
Ustekinumab 5 mg/mL	Ustekinumab	-

Primary Outcome Measures

Name	Time	Method
Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])	Day 0 through Day 113	The AUC(0-inf) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Maximum Observed Plasma Concentration (Cmax)	Day 0 through Day 113	The Cmax is the maximum observed plasma concentration of study drug.

Secondary Outcome Measures

Name	Time	Method
Volume of distribution (Vz)	Day 0 through Day 113	The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Baseline up to Day 141	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product and does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that meets any of the following conditions: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Total systemic clearance (CL)	Day 0 through Day 113	The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])	Day 0 through Day 113	The AUC(0-last) is the area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Terminal half-life (T1/2)	Day 0 through Day 113	The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.
Number of participants with antibodies to ustekinumab	Baseline, Days 57 and 113	Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported.