Clinical trial NCT02156375: A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
Official title: A Phase 1, Randomized, Open-label, Parallel-design Study to Compare Single-dose Pharmacokinetics of Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Ustekinumab
STELARA®
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 0 through Day 113
measure: Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])
timeFrame: Day 0 through Day 113
Secondary outcomes:
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline up to Day 141
measure: Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])
timeFrame: Day 0 through Day 113
measure: Terminal half-life (T1/2)
timeFrame: Day 0 through Day 113
measure: Total systemic clearance (CL)
timeFrame: Day 0 through Day 113
measure: Volume of distribution (Vz)
timeFrame: Day 0 through Day 113
measure: Number of participants with antibodies to ustekinumab
timeFrame: Baseline, Days 57 and 113
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: Lincoln
country: United States
state: Nebraska
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: