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Completed

NCT Number: NCT02295813

Safety and Pharmacokinetics Study of FBF001

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

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Key information

Conditions

Avian Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FBF001

Biological

Placebo

Drug

Other names: Sodium chloride 0.9%

Primary outcomes

  1. Blood pressure

    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

    mmHg

  2. ECG evaluation

    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

    12-lead ECG

  3. Haematology

    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

    Normal values of haematology parameters

  4. Complement activation assay

    Time frame: Before dosing, at the end of infusion and 2hours after the beginning

    ng/mL

  5. Heart rate

    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

    bpm

  6. Oral temperature

    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

    Celcius degree

  7. Body weight

    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

    kg

  8. Blood chemistry

    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

    Normal values of blood chemistry parameters

Sponsors and collaborators

Lead sponsor

Fab'entech

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
First posted
Nov 20, 2014
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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