Crohn Disease Clinical Trial
Official title:
An Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese Subjects
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have ulcerative colitis (UC) or Crohn's disease (CD). This study will look
at the PK, safety, and tolerability of vedolizumab following a single intravenous infusion of
vedolizumab IV in healthy adult Chinese participants.
The study will enroll approximately 16 participants. All participants will be assigned to
receive a single dose of vedolizumab IV 300 mg on Day 1.
This single center trial will be conducted in China. The overall time to participate in this
study is approximately 7 months. Participants will make multiple visits to the clinic, and
will be contacted by telephone, 6 months after single dose of study drug for a follow-up
safety survey assessment.
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