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The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIS410 | Experimental | VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg |
|
| Placebo | Placebo Comparator | Placebo administered as a single infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIS410 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Incidence of adverse events | 120 days post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis | Serum concentration-time profile | 56 days post-infusion |
| Immunogenicity | Detect and measure anti-drug antibodies to VIS410 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J K Berg, MD | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27077121 | Derived | Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613160 | VIS410 monoclonal antibody |
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|
| 120 days post-infusion |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |