Safety and Pharmacokinetics Study of FBF001

Fab'entech

Status and phase: Completed; Phase 1

Conditions: Avian Influenza

Treatments: Drug: Placebo; Biological: FBF001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02295813

201101H-TOLPKE

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: Male

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

FBF001

Experimental group

Description:

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.

Treatment:

Biological: FBF001

Placebo

Placebo Comparator group

Description:

The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days.

Treatment:

Drug: Placebo