Avian Influenza
Conditions
Brief summary
The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
Interventions
BIOLOGICALFBF001
DRUGPlacebo
Sponsors
Fab'entech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | mmHg |
| ECG evaluation | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | 12-lead ECG |
| Haematology | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | Normal values of haematology parameters |
| Complement activation assay | Before dosing, at the end of infusion and 2hours after the beginning | ng/mL |
| Heart rate | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | bpm |
| Oral temperature | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | Celcius degree |
| Body weight | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | kg |
| Blood chemistry | The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization | Normal values of blood chemistry parameters |
Outcome results
None listed