Study of VIR-2482 in Healthy Volunteers

Influenza A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033406
• Other study ID #: VIR-2482-3001
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: June 2022
• Source: Vir Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza A
• Influenza, Human

Intervention

Drug:
• VIR-2482
VIR-2482 given by intramuscular injection
• Placebo
Sterile normal saline (0.9% NaCl) given by intramuscular injection

Locations

Country	Name	City	State
Australia	Investigative Site	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Vir Biotechnology, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events.		Up to 12 months post-dose
Primary	Number of participants with abnormalities in vital signs.		Up to 12 months post-dose
Primary	Number of participants with abnormalities in electrocardiogram (ECG).		Up to 12 months post-dose
Primary	Number of participants with abnormalities in clinically significant laboratory findings.		Up to 12 months post-dose
Secondary	Concentrations of VIR-2482 in serum		Up to 12 months post-dose
Secondary	Incidence of anti-drug antibody (ADA) to VIR-2482		Up to 12 months post-dose
Secondary	Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482		Up to 12 months post-dose