https://www.selleckchem.com/products/vt104.html Dalcinonacog alfa (DalcA), a next-generation, recombinant human factor IX (FIX) variant, was developed using a rational design approach for increased procoagulant activity and longer duration of action to be administered subcutaneously (SC) for prophylaxis of hemophilia B bleeding episodes. To investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DalcA. This multicenter, phase 1/2a study (NCT03186677) was conducted in 11 males aged 12 to 65years with severe hemophilia B. In cohort 1, subjects received intravenous (IV) 75IU/kg BeneFIX and DalcA. Cohorts 2 and 3 had DalcA IV 75IU/kg and SC 75IU/kg or 150IU/kg. Cohort 4 was omitted. Cohort 5 received daily SC 150IU/kg DalcA for 6days and cohort 6 received IV 75IU/kg and daily SC 150IU/kg DalcA for 9days. Blood sampling was performed for chemistry, hematology, PK, PD, and anti-drug antibody measurement. Subjects were monitored for safety endpoints for 30days postdosing. DalcA demonstrated a 24-fold greater potency over BeneFIX and longer mean residence time (33.8h). SC bioavailability 8.2% to 20.3%, beta half-life 53.9 to 106.9h and T 24 to 48h. A median 15.7% FIX activity level (interquartile range, 14.9%-16.6%) was reached after 6 daily doses. Neutralizing antibodies to ISU304, but not wild-type FIX, occurred in two cousins. The data demonstrated that DalcA achieved protective FIX activity levels between 11% and 18%, corresponding to a reduced chance of spontaneous bleeds. Based on the results, a phase 2b trial to assess the safety and efficacy of 28 daily SC doses of DalcA was performed. The data demonstrated that DalcA achieved protective FIX activity levels between 11% and 18%, corresponding to a reduced chance of spontaneous bleeds. Based on the results, a phase 2b trial to assess the safety and efficacy of 28 daily SC doses of DalcA was performed. To validate the use of Seegene Allplex™ Vaginitis assay in the diagnosis of candidiasis, bacterial