Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-01 @ 6:21 PM
Study NCT ID:
NCT04704232
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008758', 'term': "5'-palmitoyl cytarabine"}]}}, '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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs', 'timeFrame': '5 days', 'description': 'Exploratory efficacy endpoint'}, {'measure': 'Visual analog scale rating of laser induced pain', 'timeFrame': '5 days', 'description': 'Exploratory efficacy endpoint'}, {'measure': 'Number and percentage of subjects with adverse events', 'timeFrame': '5 days', 'description': 'Safety endpoint'}, {'measure': 'Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings', 'timeFrame': '5 days', 'description': 'Safety endpoint'}], 'primaryOutcomes': [{'measure': 'Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs', 'timeFrame': '5 Days', 'description': 'Not defined as primary as per protocol, but system does not seem to allow omittance of primaries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin exposed to ultraviolet radiation', 'detailedDescription': 'This is an exploratory study, no primary or secondary endpoints are being defined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer\n* Fitzpatrick skin type II or III\n* Women not childbearing potential or highly effective contraception\n\nExclusion Criteria:\n\n* Pregnancy, lactation\n* Drug abuse\n* Clinically significant illness\n* Positive COVID 19 test at screening or COVID 19 infection in the past'}, 'identificationModule': {'nctId': 'NCT04704232', 'briefTitle': 'Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AlzeCure Pharma'}, 'officialTitle': 'Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D8000CI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACD440', 'description': 'Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure.', 'interventionNames': ['Drug: ACD440']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure.', 'interventionNames': ['Drug: PLAC']}], 'interventions': [{'name': 'ACD440', 'type': 'DRUG', 'description': 'Double blind, parallel within subject comparison', 'armGroupLabels': ['ACD440']}, {'name': 'PLAC', 'type': 'DRUG', 'description': 'Double blind, parallel within subject comparison', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'AlzeCure Pharma investigational site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlzeCure Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}