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Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability and Immunogenicity of MSB11456, US-licensed Actemra and EU-approved RoActemra in Healthy Adult Subjects

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Trial Profile

Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability and Immunogenicity of MSB11456, US-licensed Actemra and EU-approved RoActemra in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Jul 2023

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Autoimmune disorders; Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Fresenius Kabi

    • Most Recent Events

    • 21 Jul 2023 According to a Fresenius Kabi Media Release, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP).
    • 09 Nov 2021 Results assessing the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of MSB11456 to US-licensed and EU-approved tocilizumab and provided data on the similarity of safety profiles and immunogenicity of MSB11456 and the reference products in healthy adult subjects, presented at the ACR Convergence 2021.
    • 07 Sep 2021 According to a Fresenius Kabi media release, Primary endpoint (Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra) has been met.

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