Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.

Inclusion Criteria:

• Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
• No clinically important abnormal physical, laboratory, ECG findings
• Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion Criteria:

• Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
• Any autoimmune disease.
• Previous allergic reaction to immunoglobulin.
• Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
• Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
• Abnormal platelet function or clinically significant out of range values for any coagulation tests.
• History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
• Screening FVIII:C < 50%.