Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:20 AM
Study NCT ID:
NCT07476157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve during dosing interval (AUCt)', 'timeFrame': 'pre-dose (0hour) to 36hours', 'description': 'AUCt of AD-118'}, {'measure': 'Maximum concentration of drug in plasma (Cmax)', 'timeFrame': 'pre-dose (0hour) to 36hours', 'description': 'Cmax of AD-118'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit\n* Subjects aged 19 years or older and under 65 years at the screening visit\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT07476157', 'briefTitle': 'A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'AD-118BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1 : Reference drug(AD-1181), Period 2 : Test drug(AD-118)\n\nSingle-dose oral administration of AD-1181 in Period 1, followed by single-dose oral administration of AD-118 in Period 2.', 'interventionNames': ['Drug: AD-118, AD-1181']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Period 1 : Test drug(AD-118), Period 2 : Reference drug(AD-1181)\n\nSingle-dose oral administration of AD-118 in Period 1, followed by single-dose oral administration of AD-1181 in Period 2.', 'interventionNames': ['Drug: AD-118, AD-1181']}], 'interventions': [{'name': 'AD-118, AD-1181', 'type': 'DRUG', 'description': 'Single-dose oral administration of AD-118 or AD-1181, according to randomized sequence.', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'H PLUS YANGJI HOSPITAL, Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JaeHun Jung', 'role': 'CONTACT', 'email': 'jhjung@addpharma.co.kr', 'phone': '+82-31-891-5683'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}