Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-09 @ 11:41 AM
Study NCT ID:
NCT04033406
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of VIR-2482 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events.', 'timeFrame': 'Up to 12 months post-dose'}, {'measure': 'Number of participants with abnormalities in vital signs.', 'timeFrame': 'Up to 12 months post-dose'}, {'measure': 'Number of participants with abnormalities in electrocardiogram (ECG).', 'timeFrame': 'Up to 12 months post-dose'}, {'measure': 'Number of participants with abnormalities in clinically significant laboratory findings.', 'timeFrame': 'Up to 12 months post-dose'}], 'secondaryOutcomes': [{'measure': 'Concentrations of VIR-2482 in serum', 'timeFrame': 'Up to 12 months post-dose'}, {'measure': 'Incidence of anti-drug antibody (ADA) to VIR-2482', 'timeFrame': 'Up to 12 months post-dose'}, {'measure': 'Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482', 'timeFrame': 'Up to 12 months post-dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza A'], 'conditions': ['Influenza A']}, 'referencesModule': {'references': [{'pmid': '38376227', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Male or Female age 18 to \\< 65 years\n* Body mass index (BMI) of 18.0 kg/m\\^2 to 32.0kg/m\\^2\n\nExclusion Criteria:\n\n* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation\n* History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization.\n* Fever-like illness within 5 days of randomization.\n* History or clinical evidence of conditions considered high risk for developing influenza-related complications.'}, 'identificationModule': {'nctId': 'NCT04033406', 'briefTitle': 'Study of VIR-2482 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vir Biotechnology, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness', 'orgStudyIdInfo': {'id': 'VIR-2482-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIR-2482', 'description': 'VIR-2482', 'interventionNames': ['Drug: VIR-2482']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIR-2482', 'type': 'DRUG', 'description': 'VIR-2482 given by intramuscular injection', 'armGroupLabels': ['VIR-2482']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile normal saline (0.9% NaCl) given by intramuscular injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigative Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}