Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04877769
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2021-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bronchopulmonary PK of AT-527 (R07496998)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713067', 'term': 'AT-511'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of AT-527 in epithelial lining fluid', 'timeFrame': '4-5 hours after last dose and 11-12 hours after last dose'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must agree to use birth control, as required by the protocol.\n* Females must have a negative pregnancy test at Screening and prior to dosing\n* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2\n* Willing to comply with the study requirements and to provide written informed consent\n\nExclusion Criteria:\n\n* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 28 days of dosing\n* Concomitant use of prescription medications, or systemic over-the-counter medications\n* Other clinically significant medical conditions or laboratory abnormalities'}, 'identificationModule': {'nctId': 'NCT04877769', 'briefTitle': 'Bronchopulmonary PK of AT-527 (R07496998)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19', 'orgStudyIdInfo': {'id': 'AT-03A-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT-527 Group A', 'description': 'n=8', 'interventionNames': ['Drug: AT-527']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 Group B', 'description': 'n=8', 'interventionNames': ['Drug: AT-527']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 Group C', 'description': 'n=8', 'interventionNames': ['Drug: AT-527']}], 'interventions': [{'name': 'AT-527', 'type': 'DRUG', 'otherNames': ['RO7496998'], 'description': 'administered twice daily (BID) for 2.5 days (5 doses in total)', 'armGroupLabels': ['AT-527 Group A', 'AT-527 Group B', 'AT-527 Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Atea Study Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}