Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-27 @ 9:52 PM
Study NCT ID:
NCT02668367
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours', 'timeFrame': '0-24 hours'}, {'measure': 'Number of adverse events', 'timeFrame': 'Day -1 to Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Viral Diseases', 'Antiviral', 'Paramyxoviridae Infections', 'RSV', 'Respiratory Syncytial Virus', 'Aviragen Therapeutics, Inc.', 'Aviragen Therapeutics', 'Aviragen'], 'conditions': ['Pharmacokinetics', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy men and women;\n2. Age 18 to 60 years, inclusive;\n3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;\n4. Female subjects must be of non-childbearing potential;\n5. Male subjects must agree to use a double barrier method of birth control;\n6. Signed informed consent form (ICF) prior to study procedures.\n\nExclusion Criteria:\n\n1. Current or recent (within 14 days of Day 0) bacterial or viral infection;\n2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;\n3. Clinically significant abnormalities noted on ECG;\n4. Safety laboratory abnormalities;\n5. Regular use of medications, prescription or non-prescription;\n6. Poor vein access or fear of venipuncture or sight of blood;\n7. Major surgery, significant recent injury or trauma within 30 days;\n8. Received an investigational drug or vaccine within 30 days.'}, 'identificationModule': {'nctId': 'NCT02668367', 'briefTitle': 'Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxart'}, 'officialTitle': 'A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BTA585-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BTA-C585 oral capsules', 'description': '100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg', 'interventionNames': ['Drug: BTA-C585 oral capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BTA-C585 matching placebo', 'description': 'BTA-C585 Matching placebo capsules; single doses', 'interventionNames': ['Drug: BTA-C585 matching placebo']}], 'interventions': [{'name': 'BTA-C585 oral capsules', 'type': 'DRUG', 'otherNames': ['BTA585'], 'description': 'BTA-C585; Multiple ascending doses from 100 mg to 600 mg', 'armGroupLabels': ['BTA-C585 oral capsules']}, {'name': 'BTA-C585 matching placebo', 'type': 'DRUG', 'otherNames': ['BTA585'], 'description': 'Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules', 'armGroupLabels': ['BTA-C585 matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Biota Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Anna Novotney-Barry', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biota Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biota Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}