A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | December 2014 |
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
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.
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.
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.
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
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials