A non-randomized, open-label study to evaluate the safety, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.
Male ≥18 years and ≤65years of age;
Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products;
The subject had at least 3 or more bleeding events and/or chronic hemophilia arthritis in one or more joints in the previous 1 year requiring treatment with FIX agents;
Agree to use reliable barrier contraception and prohibition of sperm donation until 52 weeks after the administration of ZS801.
Hypersensitivity to any component of the study drug (including immunosuppressants) or a condition that can not use;
Inability to tolerate immunosuppressants or steroid drugs;
Have FIX inhibitor as assessed by laboratory; or documented history of FIX inhibitor;
History of malignancy or current presence of any malignancy;