Title
Safety and Pharmacokinetics Study of FBF001
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
Phase
Phase 1Lead Sponsor
Fab'entechStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Avian InfluenzaIntervention/Treatment
fbf001 ...Study Participants
16The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
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.
The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days.
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
