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This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIR-2482 | Experimental | VIR-2482 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2482 | Drug | VIR-2482 given by intramuscular injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events. | Up to 12 months post-dose | |
| Number of participants with abnormalities in vital signs. | Up to 12 months post-dose | |
| Number of participants with abnormalities in electrocardiogram (ECG). | Up to 12 months post-dose | |
| Number of participants with abnormalities in clinically significant laboratory findings. | Up to 12 months post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of VIR-2482 in serum | Up to 12 months post-dose | |
| Incidence of anti-drug antibody (ADA) to VIR-2482 | Up to 12 months post-dose | |
| Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Brisbane | Queensland | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38376227 | Derived | Plotnik D, Sager JE, Aryal M, Fanget MC, Peter A, Schmid MA, Cebrik D, Mogalian E, Boundy K, Yeh WW, Griffin P, Reyes M. A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness. Antimicrob Agents Chemother. 2024 Apr 3;68(4):e0127323. doi: 10.1128/aac.01273-23. Epub 2024 Feb 20. |
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| Drug |
Sterile normal saline (0.9% NaCl) given by intramuscular injection |
|
| Up to 12 months post-dose |