Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT02703051
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2016-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654285', 'term': 'uproleselan'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of subsets of WBC', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events as a measure of safety and tolerability', 'timeFrame': '19 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.\n2. Medically healthy with no clinically significant screening results as deemed by the PI.\n\nExclusion Criteria:\n\n1. History of presence of clinically significant medical condition or disease in the opinion of the PI.\n2. Alcoholism or drug abuse.\n3. Liver disease.\n4. Female subjects who are pregnant or lactating.\n5. Known history or evidence of active hepatitis A, B, or C or HIV.\n6. Clinically significant cardiovascular disease.\n7. Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.'}, 'identificationModule': {'nctId': 'NCT02703051', 'briefTitle': 'A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlycoMimetics Incorporated'}, 'officialTitle': 'A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'GMI-1271-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GMI-1271', 'description': 'GMI-1271', 'interventionNames': ['Drug: GMI-1271', 'Drug: Placebo Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filgrastim', 'description': 'Filgrastim', 'interventionNames': ['Drug: Filgrastim', 'Drug: Placebo Infusion']}, {'type': 'EXPERIMENTAL', 'label': 'GMI-1271 with Filgrastim', 'description': 'GMI-1271 with Filgrastim', 'interventionNames': ['Drug: GMI-1271', 'Drug: Filgrastim']}], 'interventions': [{'name': 'GMI-1271', 'type': 'DRUG', 'armGroupLabels': ['GMI-1271', 'GMI-1271 with Filgrastim']}, {'name': 'Filgrastim', 'type': 'DRUG', 'armGroupLabels': ['Filgrastim', 'GMI-1271 with Filgrastim']}, {'name': 'Placebo Injection', 'type': 'DRUG', 'armGroupLabels': ['GMI-1271']}, {'name': 'Placebo Infusion', 'type': 'DRUG', 'armGroupLabels': ['Filgrastim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Laura Sterling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlycoMimetics Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Celerion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}