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

Study Overview
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Brief Summary
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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

Official Title
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A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>recombinant FVIII | Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402<br>* Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402<br>* Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coagulation parameters after rFVIII administration |  | To study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration |  | To study end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interaction with recombinant FVIII