Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-29 @ 8:54 PM
Study NCT ID:
NCT05219461
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': '14 days from baseline', 'description': "* sign and symptoms of AE\n* physical exam, vital signs, ECG exam, lab test\n* ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc\n* Immunogenicity test (anti-drug antibody)"}], 'secondaryOutcomes': [{'measure': 'PK characteristics', 'timeFrame': '14 days from baseline', 'description': 'Cmax in single dose administration period'}, {'measure': 'PK characteristics', 'timeFrame': '14 days from baseline', 'description': 'AUC in single dose administration period'}, {'measure': 'PK characteristics', 'timeFrame': '14 days from baseline', 'description': 'Cmax in multiple dose adminitration period'}, {'measure': 'PK characteristics', 'timeFrame': '14 days from baseline', 'description': 'AUC in multiple dose administration period'}, {'measure': 'PK characteristics', 'timeFrame': '14 days from baseline', 'description': 'Cav in multiple dose administration period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects', 'detailedDescription': 'Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male aged from 20 to 51 at screening test\n* Weight 50kg \\~100kg BMI 18-27\n* Those who are fully understood, voluntarily decided to participate and signed prior to screening\n* Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc\n\nExclusion Criteria:\n\n* Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)'}, 'identificationModule': {'nctId': 'NCT05219461', 'briefTitle': 'Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Bio Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'DW_EGF102OP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A rhEGF 10mcg/mL', 'description': 'single dose of rhEGF 10mcg/mL eye drop or single dose of placebo\n\n\\*single dose means daily dose (administration twice daily)', 'interventionNames': ['Drug: Single dose of rhEGF 10mcg/ml or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B rhEGF 50mcg/mL', 'description': 'single dose of rhEGF 50mcg/mL eye drop or single dose of placebo\n\n\\*single dose means daily dose (administration twice daily)', 'interventionNames': ['Drug: Single dose of rhEGF 50mcg/ml or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C rhEGF 100mcg/mL', 'description': 'single dose of rhEGF 100mcg/mL eye drop or single dose of placebo\n\n\\*single dose means daily dose (administration twice daily)', 'interventionNames': ['Drug: Single dose of rhEGF 100mcg/ml or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group D rhEGF 10mcg/mL', 'description': 'multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo', 'interventionNames': ['Drug: Multiple dose of rhEGF 10mcg/ml or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group E rhEGF 50mcg/mL', 'description': 'multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo', 'interventionNames': ['Drug: Multiple dose of rhEGF 50mcg/ml or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group F rhEGF 100mcg/mL', 'description': 'multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo', 'interventionNames': ['Drug: Multiple dose of rhEGF 100mcg/ml or placebo']}], 'interventions': [{'name': 'Single dose of rhEGF 10mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group A rhEGF 10mcg/mL']}, {'name': 'Single dose of rhEGF 50mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group B rhEGF 50mcg/mL']}, {'name': 'Single dose of rhEGF 100mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group C rhEGF 100mcg/mL']}, {'name': 'Multiple dose of rhEGF 10mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group D rhEGF 10mcg/mL']}, {'name': 'Multiple dose of rhEGF 50mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group E rhEGF 50mcg/mL']}, {'name': 'Multiple dose of rhEGF 100mcg/ml or placebo', 'type': 'DRUG', 'description': '6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo', 'armGroupLabels': ['Group F rhEGF 100mcg/mL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Bio Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}