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

Janssen Research & Development, LLC140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Healthy

Interventions

UstekinumabDRUG

Participants will receive a single 6 milligram per kilogram (mg/kg) intravenous infusion of 90 milligram per milliliter (mg/mL) liquid in vial (LIV) formulation, diluted in saline, on Day 1.

UstekinumabDRUG

Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Tempe, Arizona, United States

Unnamed facility

Lincoln, Nebraska, United States

Unnamed facility

Neptune City, New Jersey, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration of study drug.

Time frame: Day 0 through Day 113

Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])

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.

Time frame: Day 0 through Day 113

Secondary Outcomes

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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.

Time frame: Baseline up to Day 141

Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])

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.

Time frame: Day 0 through Day 113

Terminal half-life (T1/2)

The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.

Time frame: Day 0 through Day 113

Total systemic clearance (CL)

Data from ClinicalTrials.gov

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