Safety and Pharmacokinetics Study of FBF001

Fab'entech16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Avian Influenza

Interventions

FBF001BIOLOGICAL

PlaceboDRUG

Eligibility

Sex: MALEMin age: 21 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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