Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT03651466
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2018-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of GX-G6 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, nature and severity of Adverse events', 'timeFrame': 'Throughout 4 weeks of study', 'description': 'All safety data will be evaluated descriptively'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics(PD) variables', 'timeFrame': 'Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing', 'description': 'Oral glucose tolerance test in mol/L'}, {'measure': 'Pharmacokinetics(PK) variables', 'timeFrame': 'Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing', 'description': 'GX-G6 concentration in blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6', 'detailedDescription': 'A screening examination will be performed within 28 days prior to dosing. Eligible subjects will return to the study center in the morning of Day -1 and will remain in-patient until discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of Day 5) if there are no safety issues. The s.c. injection will be administered in the morning of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take place on Day 15 and a final visit on Day 28.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male subjects aged between 18-50 years (both inclusive)\n2. healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing\n3. subjects who are able and willing to give written informed consent\n4. male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing.\n\nExclusion Criteria:\n\nHistory of:\n\n1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;\n2. any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;\n3. diabetes mellitus and thyroid dysfunction or other endocrine disorders;\n4. malignancy;\n5. substance abuse or addiction (alcohol, drugs) in the past 3 years.\n\n Present Condition:\n6. participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;\n7. participation in this study at a previous dose level;'}, 'identificationModule': {'nctId': 'NCT03651466', 'briefTitle': 'Safety and Tolerability of GX-G6 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genexine, Inc.'}, 'officialTitle': 'A First-in-Human, Single Ascending Dose, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Subcutaneously Administered GX-G6 in Male Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'GX-G6_HV1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(Optional) Cohort 5: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(Optional) Cohort 6: GX-G6 + placebo', 'description': 'Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects)', 'interventionNames': ['Drug: Gx-G6', 'Drug: Placebo']}], 'interventions': [{'name': 'Gx-G6', 'type': 'DRUG', 'description': 'Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.', 'armGroupLabels': ['(Optional) Cohort 5: GX-G6 + placebo', '(Optional) Cohort 6: GX-G6 + placebo', 'Cohort 1: GX-G6 + placebo', 'Cohort 2: GX-G6 + placebo', 'Cohort 3: GX-G6 + placebo', 'Cohort 4: GX-G6 + placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.', 'armGroupLabels': ['(Optional) Cohort 5: GX-G6 + placebo', '(Optional) Cohort 6: GX-G6 + placebo', 'Cohort 1: GX-G6 + placebo', 'Cohort 2: GX-G6 + placebo', 'Cohort 3: GX-G6 + placebo', 'Cohort 4: GX-G6 + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89231', 'city': 'Neu-Ulm', 'country': 'Germany', 'facility': 'NUVISAN', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'mi-sun byun, Ph. D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genexine, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genexine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}