Safety and Pharmacokinetics Study of FBF001

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.

Official Title
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A Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of One Single Intravenous Dose and 5-day Repeated Intravenous Doses of FBF001 in Healthy Male Subjects

Conditions
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Avian Influenza

Intervention / Treatment
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* Biological: FBF001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject between 21-40 years old with body mass index in the range 18 to 30 Kg/m2 Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness Any vaccination within three months before the inclusion Any vaccination against H5N1 virus Planned receipt of any vaccine during the study Any infectious disease within the month before the inclusion Any history of animal proteins allergy, animal allergy and/or any drug, food and pollen allergy Who has received blood or plasma derivatives (human or animal) in the three months preceding the initiation of the study Any medication within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FBF001<br>FBF001 must be administered by intravenous route during 1 hour. The dose must be calculated according to the body weight of the subject and diluted in sodium chloride 0.9%. FBF001 is administered once during 1 day or once per day during 5 days. | Biological: FBF001<br> <br> |
| Placebo Comparator: Placebo<br>The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days. | Drug: Placebo<br> <br> * Other names: Sodium chloride 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | mmHg | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| ECG evaluation | 12-lead ECG | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| Haematology | Normal values of haematology parameters | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| Complement activation assay | ng/mL | Before dosing, at the end of infusion and 2hours after the beginning | 
| Heart rate | bpm | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| Oral temperature | Celcius degree | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| Body weight | kg | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 
| Blood chemistry | Normal values of blood chemistry parameters | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization |