A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers
Phase of Trial: Phase I
Latest Information Update: 01 Nov 2017
At a glance
- Drugs Abatacept (Primary)
- Indications Autoimmune disorders; Inflammation
- Focus Pharmacokinetics
- Sponsors Momenta Pharmaceuticals
- 01 Nov 2017 According to a Momenta Pharmaceuticals media release, M834 did not meet its primary pharmacokinetic (PK) endpoints in this trial.
- 20 Oct 2017 Status changed from active, no longer recruiting to completed.
- 19 May 2017 Planned End Date changed from 1 Jun 2017 to 1 Jul 2017.