Safety and Pharmacokinetics Study of FBF001

November 17, 2014 updated by: Fab'entech

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: FBF001
Placebo Comparator: 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.
Drug: Placebo
Other Names:
  • Sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
Complement activation assay
Time Frame: Before dosing, at the end of infusion and 2hours after the beginning
ng/mL
Before dosing, at the end of infusion and 2hours after the beginning
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
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
The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fab'entech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201101H-TOLPKE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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