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A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and α4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects

The sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).