A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons with Severe or Moderate Hemophilia A

Prior treatment

• Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease

Other illness

• Inherited or acquired bleeding disorders other than congenital HA
• At high risk for thrombotic microangiopathy (TMA), including past personal or family history of TMA, in the investigator’s judgment
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy and to chimeric or humanized antibodies or fusion proteins

Age

• Personal history of ischemic heart disease, cerebrovascular disease, or diabetes mellitus (for participants =12 and <60 years)

Other

• Protein C activity, protein S free antigen, or anti-thrombin III activity levels below the lower limit of the reference range at screening

• Male (based on sex at birth)
• Diagnosis of severe (FVIII:C <1 IU/dL) or moderate [FVIII coagulant activity (FVIII:C) between >= 1 IU/dL and <= 5 IU/dL)] congenital hemophilia A (HA) with or without inhibitors against FVIII
• Participants with FVIII inhibitors: participants using recombinant activated factor VII (rFVIIa) or willing to switch to rFVIIa as primary bypassing agent for the treatment of breakthrough bleeds, trauma, or procedures
• Historic local FVIII inhibitor test results being available during screening to confirm any previous inhibitor history and current status
• Participants who previously successfully completed immune tolerance induction (ITI) must have done so at least 5 years before screening and must have no evidence of inhibitor recurrence (permanent or temporary) since. FVIII tolerance defined as < 0.6 bethesda unit (BU)/mL (< 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) and in vivo recovery (IVR) > 66%