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
Price :
$35
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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.