Study of VIR-2482 in Healthy Volunteers
Primary Purpose
Influenza A
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
VIR-2482
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza A focused on measuring Influenza A
Eligibility Criteria
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.
Sites / Locations
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VIR-2482
Placebo
Arm Description
VIR-2482
Placebo
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events.
Number of participants with abnormalities in vital signs.
Number of participants with abnormalities in electrocardiogram (ECG).
Number of participants with abnormalities in clinically significant laboratory findings.
Secondary Outcome Measures
Concentrations of VIR-2482 in serum
Incidence of anti-drug antibody (ADA) to VIR-2482
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04033406
Brief Title
Study of VIR-2482 in Healthy Volunteers
Official Title
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A
Keywords
Influenza A
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIR-2482
Arm Type
Experimental
Arm Description
VIR-2482
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
VIR-2482
Intervention Description
VIR-2482 given by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile normal saline (0.9% NaCl) given by intramuscular injection
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events.
Time Frame
Up to 12 months post-dose
Title
Number of participants with abnormalities in vital signs.
Time Frame
Up to 12 months post-dose
Title
Number of participants with abnormalities in electrocardiogram (ECG).
Time Frame
Up to 12 months post-dose
Title
Number of participants with abnormalities in clinically significant laboratory findings.
Time Frame
Up to 12 months post-dose
Secondary Outcome Measure Information:
Title
Concentrations of VIR-2482 in serum
Time Frame
Up to 12 months post-dose
Title
Incidence of anti-drug antibody (ADA) to VIR-2482
Time Frame
Up to 12 months post-dose
Title
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Time Frame
Up to 12 months post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigative Site
City
Brisbane
State/Province
Queensland
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study of VIR-2482 in Healthy Volunteers
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