Study of VIR-2482 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2021-11-01

Brief Summary

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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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Detailed Description

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Conditions

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Influenza A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VIR-2482

Group Type EXPERIMENTAL

VIR-2482

Intervention Type DRUG

VIR-2482 given by intramuscular injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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VIR-2482

VIR-2482 given by intramuscular injection

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes