Study of VIR-2482 in Healthy Volunteers

• Sponsor: Vir Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04033406
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.2
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza A	Drug: VIR-2482; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 26, 2019
• Actual Primary Completion Date: Nov 1, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIR-2482 VIR-2482	Drug: VIR-2482; VIR-2482 given by intramuscular injection
Placebo Comparator: Placebo Placebo	Drug: Placebo; Sterile normal saline (0.9% NaCl) given by intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-emergent adverse events. [Up to 12 months post-dose]

2. Number of participants with abnormalities in vital signs. [Up to 12 months post-dose]

3. Number of participants with abnormalities in electrocardiogram (ECG). [Up to 12 months post-dose]

4. Number of participants with abnormalities in clinically significant laboratory findings. [Up to 12 months post-dose]

Secondary Outcome Measures

1. Concentrations of VIR-2482 in serum [Up to 12 months post-dose]

2. Incidence of anti-drug antibody (ADA) to VIR-2482 [Up to 12 months post-dose]

3. Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482 [Up to 12 months post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Brisbane	Queensland	Australia

Sponsors and Collaborators

• Vir Biotechnology, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vir Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT04033406
• Other Study ID Numbers: VIR-2482-3001
• First Posted: Jul 26, 2019
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vir Biotechnology, Inc.: Influenza A
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jun 9, 2022