Finding studies
Finding studies
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Lead
Takeda
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
