A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02156375
- Run by
- Janssen Research & Development, LLC
- People needed
- 140
- Starts
- 2014-05-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2016-03-22
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Tempe, Arizona, United States
- Study site — Lincoln, Nebraska, United States
- Study site — Neptune City, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.