Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05791318
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Randomized, triple blind, placebo controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of TEAEs (including AEs and SAEs)', 'timeFrame': 'Through 12 Months'}], 'secondaryOutcomes': [{'measure': 'Incidence of ADAs against VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: Cmax (maximum serum concentration)', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: Clearance of VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: Half-life of VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: volume of distribution at steady state of VYD222', 'timeFrame': '12 Months'}, {'measure': 'Assessment of PK Parameter: volume of distribution during terminal phase of VYD222', 'timeFrame': '12 Months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.', 'detailedDescription': 'This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers.\n\nThe primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a body mass index 18.5 to 32.0 kg/m2, inclusive.\n* Negative for current SARS-CoV-2 infection by rapid antigen test on Day -1.\n* Is seropositive to N and/or S SARS-CoV-2 antigens at Screening.\n* For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception.\n* Is able and willing to provide written informed consent.\n* NOTE: Other protocol defined inclusion/exclusion criteria apply\n\nExclusion Criteria:\n\n* Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.\n* Is pregnant, breastfeeding, or seeking pregnancy while on study.\n* Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured.\n* Has had any symptoms of acute respiratory illness (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.\n* Has evidence of active infection with HIV, HBV, or HCV.\n* Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.\n* Had major surgery within 30 days prior to study drug dosing or planned surgeries within 12 months after planned study drug dosing.\n* Received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to Screening or planned administration of any investigational drug or biologic during the study period.\n* Received immunoglobulin or blood products within 6 months prior to Screening.\n* Previously received a mAb within 6 months or 5 half-lives (whichever is longer) prior to Screening.\n* NOTE: Other protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05791318', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invivyd, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'VYD222-1-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo', 'interventionNames': ['Drug: VYD222', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo', 'interventionNames': ['Drug: VYD222', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo', 'interventionNames': ['Drug: VYD222', 'Other: Placebo']}], 'interventions': [{'name': 'VYD222', 'type': 'DRUG', 'description': 'Monoclonal antibody', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['0.9% sodium chloride'], 'description': 'Matching Placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6027', 'city': 'Joondalup', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.74445, 'lon': 115.76835}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invivyd, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novotech (Australia) Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}