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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04033406

Enrollment

100

Registered

2019-07-26

Start date

2019-08-26

Completion date

2021-11-01

Last updated

2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A

Keywords

Influenza A

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.

Interventions

DRUGVIR-2482

VIR-2482 given by intramuscular injection

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
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
Concentrations of VIR-2482 in serum	Up to 12 months post-dose

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026