Clinical trial NCT02295813: Safety and Pharmacokinetics Study of FBF001
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of One Single Intravenous Dose and 5-day Repeated Intravenous Doses of FBF001 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Avian Influenza
Lead sponsor: Fab'entech
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Blood pressure
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: ECG evaluation
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: Haematology
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: Complement activation assay
timeFrame: Before dosing, at the end of infusion and 2hours after the beginning
measure: Heart rate
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: Oral temperature
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: Body weight
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
measure: Blood chemistry
timeFrame: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bal C, Herbreteau CH, Buchy P, Rith S, Zaid M, Kristanto W, Han V, Reynaud C, Granjard P, Lepine B, Durand C, Tambyah PA. Safety, potential efficacy, and pharmacokinetics of specific polyclonal immunoglobulin F(ab')(2) fragments against avian influenza A (H5N1) in healthy volunteers: a single-centre, randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2015 Mar;15(3):285-92. doi: 10.1016/S1473-3099(14)71072-2. Epub 2015 Feb 5.