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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

recombinant FVIII

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes