Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin

Study Overview
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Brief Summary
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Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Official Title
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A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-molecular-weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin

Conditions
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Healthy

Intervention / Treatment
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* Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects


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% 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: LMWH arm - active LMWH<br> | Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects<br>* Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin<br>|
| Placebo Comparator: LMWH arm - placebo<br> | Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects<br>* Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin<br>|
| Experimental: Warfarin arm - active warfarin<br> | Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects<br>* Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin<br>|
| Other: Warfarin arm - control<br> | Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects<br>* Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c |  | To study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm) |  | To study end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interaction with LMWH or warfarin