Title
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.
Phase
Phase 1Lead Sponsor
Oxurion NV.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HealthyIntervention/Treatment
tb-402 ...Study Participants
56Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
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%.
