A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

• Main Authors: Jim Bush (Author), Kazuki Kawakami (Author), Rafael Muniz (Author)
• Format: Knjiga
• Izdano: BMC, 2019-12-01T00:00:00Z.
• Teme: article
• Online dostop: Connect to this object online.

Abstract Background/objective FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), i...