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A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects

Trial Profile

A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2020

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis; Uveitis
  • Focus Pharmacokinetics
  • Sponsors Fresenius Kabi

Most Recent Events

  • 23 Mar 2020 Status changed from active, no longer recruiting to completed.
  • 05 Feb 2020 Planned End Date changed from 1 Feb 2020 to 17 Mar 2020.
  • 05 Feb 2020 Planned primary completion date changed from 1 Feb 2020 to 17 Mar 2020.

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