drugset / Trial / NCT02156375
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 6 mg/kg | Intravenous |
Indications
No indication recorded.