At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Vedolizumab SCdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Vedolizumab SC for Healthy Volunteers. Completed, enrolled 24 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
Primary CompletionJul 2018
Study CompletionAug 2018
First PostedMay 2019
TodayJul 2026
First PostedMay 14, 2019
Enrollment StartFeb 6, 2018
Primary CompletionJul 2, 2018
Study CompletionAug 13, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.1 years ago
Interventions
Vedolizumab SCdrug
Vedolizumab SC liquid.