Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
- Registration Number
- NCT00612417
- Lead Sponsor
- ThromboGenics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 recombinant FVIII 2 Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 Placebo
- Primary Outcome Measures
Name Time Method Changes in coagulation parameters after rFVIII administration To study end
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cyncron CRU
🇩🇰Copenhagen, Denmark