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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612417

Enrollment

Registered

2008-02-11

Start date

2008-01-31

Completion date

2008-06-30

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Interaction with recombinant FVIII

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in coagulation parameters after rFVIII administration	To study end

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026