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
Overview
- Phase
- Phase 1
- Intervention
- FBF001
- Conditions
- Avian Influenza
- Sponsor
- Fab'entech
- Enrollment
- 16
- Primary Endpoint
- Haematology
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: FBF001
Placebo
The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Haematology
Time Frame: 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
Blood pressure
Time Frame: 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
Time Frame: 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
Complement activation assay
Time Frame: Before dosing, at the end of infusion and 2hours after the beginning
ng/mL
Body weight
Time Frame: 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
Heart rate
Time Frame: 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
Time Frame: 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
Blood chemistry
Time Frame: 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