Status:
COMPLETED
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
Lead Sponsor:
ThromboGenics
Collaborating Sponsors:
BioInvent International AB
Conditions:
Healthy
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00612196
Start Date
March 1 2007
End Date
December 1 2007
Last Update
April 7 2014
Active Locations (1)
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1
Cyncron Clinical Research Unit
Copenhagen, Denmark, DK-2100