Safety and Pharmacokinetics Study of FBF001
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
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedNovember 20, 2014
November 1, 2014
2 months
November 12, 2014
November 17, 2014
Conditions
Outcome Measures
Primary Outcomes (8)
Blood pressure
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
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
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
ng/mL
Before dosing, at the end of infusion and 2hours after the beginning
Heart rate
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
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
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
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
Study Arms (2)
FBF001
EXPERIMENTALFBF001 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.
Placebo
PLACEBO COMPARATORThe placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days.
Interventions
Eligibility Criteria
You may qualify if:
- subject between 21-40 years old
- with body mass index in the range 18 to 30 Kg/m2
You may not qualify if:
- 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 against H5N1 virus
- Planned receipt of any vaccine during the study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fab'entechlead
Related Publications (1)
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.
PMID: 25662592DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2014
First Posted
November 20, 2014
Study Start
October 1, 2012
Primary Completion
December 1, 2012
Last Updated
November 20, 2014
Record last verified: 2014-11