Study of VIR-2482 in Healthy Volunteers
- Registration Number
- NCT04033406
- Lead Sponsor
- Vir Biotechnology, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Healthy Male or Female age 18 to < 65 years
- Body mass index (BMI) of 18.0 kg/m^2 to 32.0kg/m^2
Exclusion Criteria
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization.
- Fever-like illness within 5 days of randomization.
- History or clinical evidence of conditions considered high risk for developing influenza-related complications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo VIR-2482 VIR-2482 VIR-2482
- Primary Outcome Measures
Name Time Method Number of participants with abnormalities in vital signs. Up to 12 months post-dose Number of participants with abnormalities in clinically significant laboratory findings. Up to 12 months post-dose Number of participants with abnormalities in electrocardiogram (ECG). Up to 12 months post-dose Number of participants with treatment-emergent adverse events. Up to 12 months post-dose
- Secondary Outcome Measures
Name Time Method Incidence of anti-drug antibody (ADA) to VIR-2482 Up to 12 months post-dose Concentrations of VIR-2482 in serum Up to 12 months post-dose Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482 Up to 12 months post-dose
Trial Locations
- Locations (1)
Investigative Site
🇦🇺Brisbane, Queensland, Australia