Trial Profile

A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of three formulations of adalimumab (M923, US Sourced Humira and EU Sourced Humira) in healthy subjects

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 04 Jul 2022

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At a glance

08 Jun 2016 According to a Momenta media release, key data from this trial will be presented at the European League Against Rheumatism Annual Congress (EULAR) 2016 Annual Meeting.
18 Aug 2015 Status changed from recruiting to completed as per ISRCTN: Current Controlled Trials record.
04 Aug 2015 According to a Momenta Pharmaceuticals media release, the target date for the first regulatory submission for approval is 2017.

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