Phase 1 study of ACE910 in healthy volunteers and hemophilia A patients

INTERVENTION: Intervention name : ACE910 INN of the intervention : emicizumab Dosage And administration of the intervention : Single and multiple subcutaneous administration of several doses of ACE910 CONDITION: Hemophilia A PRIMARY OUTCOME: Tolerability, Safety, Pharmacokinetics, Pharmacodynamics INCLUSION CRITERIA: [Healthy volunteer] ‐ Japanese or Caucasian ‐ Age 20 ‐ 44 years, inclusive [Patient] ‐ Japanese severe congenital hemophilia A ‐ Age 12 ‐ 59 years, inclusive ‐ Recorded bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for six months prior to entry ‐ Meet any of the criteria below at the time of entry (1) For patient with inhibitors, exhibited bleeding more frequently than once a month for six months prior to entry (2) For patient without inhibitors, administered factor VIII products more than 150 times prior to entry, and underwent prophylaxis for six months prior to entry