Safety and Pharmacokinetics Study of FBF001

Phase 1

Completed

• Conditions: Avian Influenza
• Interventions: Drug: Placebo; Biological: FBF001

• Registration Number: NCT02295813
• Lead Sponsor: Fab'entech

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-12
• Status Verified: 2014-11
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
FBF001	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.

Primary Outcome Measures

Name	Time	Method
Haematology	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	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	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	Before dosing, at the end of infusion and 2hours after the beginning	ng/mL
Body weight	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	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	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	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