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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBF001 | Experimental | 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. |
|
| Placebo | Placebo Comparator | The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FBF001 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25662592 | Derived | 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. |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| 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 |
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |
| D017670 |
| Sodium Compounds |