Journal of Bioequivalence & Bioavailability

Department of Clinical Pharmacology, Galderma R and D, Zug, Switzerland; Celerion, Lincoln, USA

Publications

• Research Article   
  Pharmacokinetic Bridging Study To Support The Use Of Nemolizumab Prefilled Pen For The Treatment Of Atopic Dermatitis And Prurigo Nodularis
  Author(s): Luca Loprete*, Jabbar Lopez Z, Piketty C, Rasmussen S, Silverberg J, Stander S, Duval V, Machu JL, Ulianov L and Wagner N
  
  Background: Nemolizumab is a monoclonal antibody that targets the receptor alpha of the neuro-immune cytokine IL-31. This clinical PK bridging study was conducted to support the marketing application of the prefilled dual chamber pen. Methods: This was a phase 1, randomized, multicenter, open-label, single-dose, parallel-group study in healthy adult subjects. Participants (N=192) were randomized by device (pen or syringe) and by injection site (abdomen, thigh, arm) and received one subcutaneous 60 mg nemolizumab dose. The primary endpoint pharmacokinetic parameters were analyzed using a linear mixed-effect model. Safety data were summarized descriptively. Results: Mean age was 41.5 years (19 to 65 years), mean body weight was 72.76 kg (45.4 to 107.4 kg) and 61% of participants were female. The geometric least-square mean ratio comparing pen versus syringe was 105.90% for Cmax and 97.6.. View more»
  

  DOI: 10.35248/0975-0851.25.17.643

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