Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04722627
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of AT-752 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728630', 'term': 'AT-752'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events', 'timeFrame': 'Day 6 for single dose or Day 12 for multiple dose'}, {'measure': 'Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses', 'timeFrame': 'Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses', 'timeFrame': 'Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose', 'timeFrame': 'Day 1 for subjects receiving a single fed dose]', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose', 'timeFrame': 'Day 1 for subjects receiving a single fed dose ]', 'description': 'Area under the concentration-time curve (AUC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dengue']}, 'referencesModule': {'references': [{'pmid': '38526047', 'type': 'DERIVED', 'citation': 'Zhou X-J, Lickliter J, Montrond M, Ishak L, Pietropaolo K, James D, Belanger B, Horga A, Hammond J. First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus. Antimicrob Agents Chemother. 2024 May 2;68(5):e0161523. doi: 10.1128/aac.01615-23. Epub 2024 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects', 'detailedDescription': 'A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index (BMI) of 18-29 kg/m2\n2. Must agree to use protocol-specified methods of contraception\n3. Negative pregnancy test\n4. Willing to comply with the study requirements and to provide written informed consent\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Abuse of alcohol or drugs\n3. Use of other investigational drugs within 30 days of dosing\n4. Other clinically significant medical conditions'}, 'identificationModule': {'nctId': 'NCT04722627', 'briefTitle': 'Study of AT-752 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AT-02A-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT-752 250 mg single dose', 'description': 'AT-752 administered orally, 250 mg on Day 1', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo -single dose', 'description': 'Matching placebo administered orally on Day 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 500 mg single dose', 'description': 'AT-752 administered orally, 500 mg single doses on Day 1 and Day 7', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo- single dose', 'description': 'Matching placebo administered orally on Day 1 and Day 7', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 1000 mg single dose', 'description': 'AT-752 administered orally, 1000 mg single dose on Day 1', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - single dose', 'description': 'Matching placebo administered orally on Day 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 1500 mg single dose', 'description': 'AT-752 administered orally, 1500 mg single dose on Day 1', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: single dose', 'description': 'Matching placebo administered orally on Day 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 - 1000 mg QD multiple doses', 'description': 'AT-752 - administered orally, 1000 mg once daily (QD) for 7 days', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Administered once daily (QD)', 'description': 'Matching placebo administered orally once daily (QD) for 7 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 - 750 mg twice daily (BID)', 'description': 'AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Administered twice daily (BID)', 'description': 'Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-752 - 750 mg three times daily (TID)', 'description': 'AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.', 'interventionNames': ['Drug: AT-752']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Administered TID', 'description': 'Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AT-752', 'type': 'DRUG', 'description': 'Parallel Assignment', 'armGroupLabels': ['AT-752 - 1000 mg QD multiple doses', 'AT-752 - 750 mg three times daily (TID)', 'AT-752 - 750 mg twice daily (BID)', 'AT-752 1000 mg single dose', 'AT-752 1500 mg single dose', 'AT-752 250 mg single dose', 'AT-752 500 mg single dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Parallel Assignment', 'armGroupLabels': ['Placebo - Administered TID', 'Placebo - Administered once daily (QD)', 'Placebo - Administered twice daily (BID)', 'Placebo - single dose', 'Placebo -single dose', 'Placebo- single dose', 'Placebo: single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Atea Study Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}