Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Open-Label, Randomized, Parallel Group Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Needle Safety Device in Healthy Subjects
The purpose of this study is to compare the 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. This study will compare the PK
of a vedolizumab SC dose in PFS to an investigational device in healthy participants.
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 (per randomization schedule) 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 long-term follow-up (LFTU)
assessment which will involve the progressive multifocal leukoencephalopathy (PML)
questionnaire survey.
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