Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-03-04 @ 7:07 PM
Study NCT ID:
NCT02516904
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Ascending Dose Study of CD101 IV in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623143', 'term': 'echinocandin CD101 IV'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with clinically significant adverse events (AEs)', 'timeFrame': 'Up to 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)', 'timeFrame': 'Up to 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV', 'detailedDescription': 'This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males surgically sterilized or using contraception,\n* No significant findings on physical, ECG, clinical laboratory tests,\n* BMI between 18.5 - 32.0,\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Females of child bearing potential,\n* Signs and or symptoms of an acute or chronic illness,\n* Use of prescription medications within 28 days,\n* Use of OTC, supplements, and herbals within 14 days,\n* Current smoker\n* Previous participation in a clinical study within 28 days'}, 'identificationModule': {'nctId': 'NCT02516904', 'briefTitle': 'A Single Ascending Dose Study of CD101 IV in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cidara Therapeutics Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CD101.IV.1.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD101 IV', 'description': 'single intravenous infusion ascending dose', 'interventionNames': ['Drug: CD101 IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'normal saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CD101 IV', 'type': 'DRUG', 'description': 'antifungal', 'armGroupLabels': ['CD101 IV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion Inc', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Danielle Armas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cidara Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}