Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT03329209
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vedolizumab intravenous infusion.
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Takeda
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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