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
Price :
$35
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At a glance
- Drugs Tocilizumab (Primary)
- Indications Autoimmune disorders; Rheumatoid arthritis
- Focus Pharmacokinetics
- Sponsors Fresenius Kabi
- 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.