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Safety and Pharmacokinetics Study of FBF001

Primary Purpose

Avian Influenza

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FBF001
Placebo
Sponsored by
Fab'entech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avian Influenza

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    FBF001

    Placebo

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Blood pressure
    mmHg
    ECG evaluation
    12-lead ECG
    Haematology
    Normal values of haematology parameters
    Complement activation assay
    ng/mL
    Heart rate
    bpm
    Oral temperature
    Celcius degree
    Body weight
    kg
    Blood chemistry
    Normal values of blood chemistry parameters

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2014
    Last Updated
    November 17, 2014
    Sponsor
    Fab'entech
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02295813
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fab'entech

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Avian Influenza

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FBF001
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Biological
    Intervention Name(s)
    FBF001
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Sodium chloride 0.9%
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Description
    mmHg
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    ECG evaluation
    Description
    12-lead ECG
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    Haematology
    Description
    Normal values of haematology parameters
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    Complement activation assay
    Description
    ng/mL
    Time Frame
    Before dosing, at the end of infusion and 2hours after the beginning
    Title
    Heart rate
    Description
    bpm
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    Oral temperature
    Description
    Celcius degree
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    Body weight
    Description
    kg
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
    Title
    Blood chemistry
    Description
    Normal values of blood chemistry parameters
    Time Frame
    The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25662592
    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.
    Results Reference
    derived

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    Safety and Pharmacokinetics Study of FBF001

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