Safety and Pharmacokinetics Study of FBF001

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fab'entech

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