Healthy Clinical Trial
Official title:
A Phase 1, Open Label, Randomized, Parallel Group Study to Assess the Absolute Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
determine its bioavailability, safety, and tolerability in the body with three varying doses
of vedolizumab SC compared to people who are administered vedolizumab IV.
The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients.
Participants will be randomly assigned to one of the four treatment groups:
- vedolizumab SC 54 mg
- vedolizumab SC 108 mg
- vedolizumab SC 160 mg
- vedolizumab IV 300 mg
All participants will receive the treatment they are assigned on Day 1 of the study.
This single-center trial will be conducted in the United Kingdom. The overall time to
participate in this study is up to 196 days. Participants will make 10 visits to the clinic,
including one 8 day period of confinement to the clinic, and will be contacted by telephone
at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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