This is a Phase 1, single center, open-label, sequential treatment, 3-period fixed sequence study to assess PK profiles of BIVV001, SHL and EHL rFVIII after a single IV injection in male, previously treated patients, 18-65 years of age, with severe hemophilia A (defined as <1 IU/dL [<1%] endogenous FVIII).~The expected duration of the study is up to approximately 67 days including~Screening and washout up to 28 days,~Advate® dosing, PK sampling, including washout: approximately 4 days,~Adynovi® dosing and PK sampling, including washout: approximately 7 days,~BIVV001 dosing and PK sampling: approximately 14 days, Remainder of Safety Observation Period: approximately 14 days.
Primary objective~• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection~Secondary objectives~To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection~To evaluate the safety and tolerability of a single IV injection of BIVV001