Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-04 @ 6:54 PM
Study NCT ID:
NCT04105959
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2019-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo', 'timeFrame': 'Blister formation to Hour 24', 'description': 'Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control'}, {'measure': 'Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo', 'timeFrame': 'Blister formation to Hour 30', 'description': 'Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control'}, {'measure': 'Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo', 'timeFrame': 'Blister formation to Hour 36', 'description': 'Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male, with Fitzpatrick skin types 1 to 3\n* Subject is aged between 18 to 55 years, inclusive\n* Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive\n* Healthy as determined by a responsible physician, based on medical evaluation\n* Must be willing to use birth control as indicated\n\nExclusion Criteria:\n\n* Subject is known to have immune deficiency or is immunocompromised\n* Subject has had a recent acute infection or chronic infection\n* Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug\n* Clinically relevant history of abnormal physical or mental health (including \\[but not limited to\\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)'}, 'identificationModule': {'nctId': 'NCT04105959', 'briefTitle': 'A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aristea Therapeutics, Inc.'}, 'officialTitle': 'A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model', 'orgStudyIdInfo': {'id': 'RIST4721-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIST4721 300mg', 'description': 'RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.', 'interventionNames': ['Drug: RIST4721', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RIST4721 150mg', 'description': 'RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.', 'interventionNames': ['Drug: RIST4721', 'Drug: Placebo']}], 'interventions': [{'name': 'RIST4721', 'type': 'DRUG', 'description': 'RIST4721 oral solution', 'armGroupLabels': ['RIST4721 150mg', 'RIST4721 300mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral solution', 'armGroupLabels': ['RIST4721 150mg', 'RIST4721 300mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9NQ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'MAC Clinical Research', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristea Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}