A non-randomized, open-label, dose-escalation, phase I/II study to evaluate the safety, tolerability, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.
Male ≥18 years of age;
Confirmed diagnosis of hemophilia B, and endogenous FIX ≤2%;
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;
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;