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
1 other identifier
interventional
100
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJune 9, 2022
June 1, 2022
2.2 years
July 22, 2019
June 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
Secondary Outcomes (3)
Concentrations of VIR-2482 in serum
Up to 12 months post-dose
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
Study Arms (2)
VIR-2482
EXPERIMENTALVIR-2482
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Male or Female age 18 to \< 65 years
- Body mass index (BMI) of 18.0 kg/m\^2 to 32.0kg/m\^2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigative Site
Brisbane, Queensland, Australia
Related Publications (1)
Plotnik D, Sager JE, Aryal M, Fanget MC, Peter A, Schmid MA, Cebrik D, Mogalian E, Boundy K, Yeh WW, Griffin P, Reyes M. A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness. Antimicrob Agents Chemother. 2024 Apr 3;68(4):e0127323. doi: 10.1128/aac.01273-23. Epub 2024 Feb 20.
PMID: 38376227DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 26, 2019
Study Start
August 26, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
June 9, 2022
Record last verified: 2022-06