NCT04033406CompletedPhase 1
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
Vir Biotechnology, Inc.1 site in 1 country100 target enrollmentStarted: August 26, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Vir Biotechnology, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of participants with abnormalities in vital signs.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
VIR-2482
Experimental
VIR-2482
Intervention: VIR-2482 (Drug)
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with abnormalities in vital signs.
Time Frame: Up to 12 months post-dose
Number of participants with abnormalities in clinically significant laboratory findings.
Time Frame: Up to 12 months post-dose
Number of participants with abnormalities in electrocardiogram (ECG).
Time Frame: Up to 12 months post-dose
Number of participants with treatment-emergent adverse events.
Time Frame: Up to 12 months post-dose
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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