Status:
COMPLETED
Safety and Pharmacokinetics Study of FBF001
Lead Sponsor:
Fab'entech
Conditions:
Avian Influenza
Eligibility:
MALE
21-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
Eligibility Criteria
Inclusion
- subject between 21-40 years old
- with body mass index in the range 18 to 30 Kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02295813
Start Date
October 1 2012
Last Update
November 20 2014
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