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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
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza A focused on measuring Influenza A

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 22, 2019
Last Updated
June 8, 2022
Sponsor
Vir Biotechnology, Inc.
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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

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Study of VIR-2482 in Healthy Volunteers

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