Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402

ThromboGenics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612417

TB-402-002

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

12 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

recombinant FVIII

Treatment:

Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402