Study of VIR-2482 in Healthy Volunteers

A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness

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 Overview

• Status: Completed
• Conditions: Influenza A
• Intervention / Treatment: Drug: VIR-2482; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Sterile normal saline (0.9% NaCl) given by intramuscular injection
Experimental: VIR-2482	Drug: VIR-2482; VIR-2482 given by intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Up to 12 months post-dose

Collaborators and Investigators

• Sponsor: Vir Biotechnology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Influenza A
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VIR-2482-3001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No