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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Ustekinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02156375

CNTO1275NAP1002

CR104186

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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