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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04033406




Registration number
NCT04033406
Ethics application status
Date submitted
22/07/2019
Date registered
26/07/2019
Date last updated
9/06/2022

Titles & IDs
Public title
Study of VIR-2482 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
VIR-2482-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIR-2482
Treatment: Drugs - Placebo

Experimental: VIR-2482 - VIR-2482

Placebo comparator: Placebo - Placebo


Treatment: Drugs: VIR-2482
VIR-2482 given by intramuscular injection

Treatment: Drugs: Placebo
Sterile normal saline (0.9% NaCl) given by intramuscular injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events.
Timepoint [1] 0 0
Up to 12 months post-dose
Primary outcome [2] 0 0
Number of participants with abnormalities in vital signs.
Timepoint [2] 0 0
Up to 12 months post-dose
Primary outcome [3] 0 0
Number of participants with abnormalities in electrocardiogram (ECG).
Timepoint [3] 0 0
Up to 12 months post-dose
Primary outcome [4] 0 0
Number of participants with abnormalities in clinically significant laboratory findings.
Timepoint [4] 0 0
Up to 12 months post-dose
Secondary outcome [1] 0 0
Concentrations of VIR-2482 in serum
Timepoint [1] 0 0
Up to 12 months post-dose
Secondary outcome [2] 0 0
Incidence of anti-drug antibody (ADA) to VIR-2482
Timepoint [2] 0 0
Up to 12 months post-dose
Secondary outcome [3] 0 0
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Timepoint [3] 0 0
Up to 12 months post-dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2021
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigative Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04033406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04033406