Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402

Inclusion Criteria include:

• Males 18 to 45 years of age
• Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

• Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
• History of important bleeding episodes
• Previous allergic reaction to immunoglobulin
• Present or previous history of severe allergy, for example asthma or anaphylactic reactions
• FVIII:C <50% or >150% at screening
• Clinically significant out of range values for any coagulation test during screening
• Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402