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
Phase of Trial: Phase I
Latest Information Update: 19 Sep 2017
At a glance
- Drugs Adalimumab (Primary)
- Indications Autoimmune disorders; Inflammation
- Focus Pharmacokinetics
- Sponsors Baxter Innovations GmbH
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History