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OpenTrials
Completed

NCT Number: NCT04033406

Study of VIR-2482 in Healthy Volunteers

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.

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Key information

Conditions

Influenza A

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site

Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIR-2482

Drug

VIR-2482 given by intramuscular injection

Placebo

Drug

Sterile normal saline (0.9% NaCl) given by intramuscular injection

Primary outcomes

  1. Number of participants with treatment-emergent adverse events.

    Time frame: Up to 12 months post-dose

  2. Number of participants with abnormalities in vital signs.

    Time frame: Up to 12 months post-dose

  3. Number of participants with abnormalities in electrocardiogram (ECG).

    Time frame: Up to 12 months post-dose

  4. Number of participants with abnormalities in clinically significant laboratory findings.

    Time frame: Up to 12 months post-dose

Secondary outcomes

  1. Concentrations of VIR-2482 in serum

    Time frame: Up to 12 months post-dose

  2. Incidence of anti-drug antibody (ADA) to VIR-2482

    Time frame: Up to 12 months post-dose

  3. Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482

    Time frame: Up to 12 months post-dose

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2019
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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