Healthy
Conditions
Keywords
Healthy, Ustekinumab, STELARA®
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.
Interventions
DRUGUstekinumab
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 0 through Day 113 | The Cmax is the maximum observed plasma concentration of study drug. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 antibodies to ustekinumab | Baseline, Days 57 and 113 | Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed