A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
- Registration Number
- NCT00612196
- Lead Sponsor
- ThromboGenics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 TB-402 - 10 Placebo - 1 TB-402 - 6 TB-402 - 8 TB-402 - 5 TB-402 - 2 TB-402 - 4 TB-402 - 9 TB-402 - 7 TB-402 -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cyncron Clinical Research Unit
🇩🇰Copenhagen, Denmark