Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
FBF001
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.
Placebo
Interventions
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FBF001
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with body mass index in the range 18 to 30 Kg/m2
Exclusion Criteria
* 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
21 Years
40 Years
MALE
Yes
Sponsors
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Fab'entech
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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201101H-TOLPKE
Identifier Type: -
Identifier Source: org_study_id