Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 5:00 AM
Study NCT ID:
NCT05844592
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human, Single Ascending Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AE', 'timeFrame': '2 weeks', 'description': 'Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and tolerability of single ascending oral doses of INV-101 in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at the screening visit.\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.\n\nExclusion Criteria:\n\n* Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.'}, 'identificationModule': {'nctId': 'NCT05844592', 'briefTitle': 'First in Human, Single Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovo Therapeutics, Inc.'}, 'officialTitle': 'A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'INV101-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Dose A', 'interventionNames': ['Drug: INV-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Dose B', 'interventionNames': ['Drug: INV-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Dose C', 'interventionNames': ['Drug: INV-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': 'Dose D', 'interventionNames': ['Drug: INV-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E', 'description': 'Dose E', 'interventionNames': ['Drug: INV-101']}], 'interventions': [{'name': 'INV-101', 'type': 'DRUG', 'description': 'subjects will be randomized 3:1 ratio', 'armGroupLabels': ['A', 'B', 'C', 'D', 'E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Innovo Therapeutics, Inc.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Minjeong Kim, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New Drug development Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovo Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}