A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.

Official Title
-----------------
A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TB-402
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age No clinically important abnormal physical, laboratory, ECG findings Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR) Exclusion Criteria: Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke. Any autoimmune disease. Previous allergic reaction to immunoglobulin. Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment. Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration. Abnormal platelet function or clinically significant out of range values for any coagulation tests. History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage. Screening FVIII:C < 50%.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 2<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 3<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 4<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 5<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 6<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 7<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 8<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Experimental: 9<br> | Drug: TB-402<br>* Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes<br>|
| Placebo Comparator: 10<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety and tolerability