The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
The drug being tested in this study is called vedolizumab SC. The study will assess the PK, and variability of a vedolizumab SC in a PFS vs investigational device. This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including 4 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups: * Group A: Vedolizumab SC PFS * Group B: Vedolizumab SC Investigational Device All participants will receive a single dose of study drug on Day 1. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Vedolizumab SC liquid.
Celerion
Lincoln, Nebraska, United States
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
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