drugset / Trial / NCT03948581

A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants

NCT03948581

Phase 1 Completed 102 enrolled Takeda
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2018-02-21
Primary completion
2018-08-14
Completion
2018-09-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 108 mg Subcutaneous

Indications

No indication recorded.