Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT06640920
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '140 days', 'description': 'To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0'}], 'secondaryOutcomes': [{'measure': 'Absolute bioavailability', 'timeFrame': '140 days', 'description': 'Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants.'}, {'measure': 'Concentration of immunogenicity', 'timeFrame': '140 days', 'description': 'Immunogenicity profile of NSI-8226 in healthy participants.'}, {'measure': 'Parameters in healthy participants', 'timeFrame': '140 days', 'description': 'Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1\\. At the time of initial screening, in general good health (age 18 to 65 years);\n\nKey Exclusion Criteria:\n\n1. Pregnancy or breastfeeding during the study.\n2. Chronic infection - Treatment with prohibited medications.\n3. Treatment with prohibited medications'}, 'identificationModule': {'nctId': 'NCT06640920', 'briefTitle': 'A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uniquity One (UNI)'}, 'officialTitle': 'A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants', 'orgStudyIdInfo': {'id': 'NSI-8226-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'description': 'NSI-8226', 'interventionNames': ['Biological: Cohort A']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B', 'description': 'NSI-8226', 'interventionNames': ['Biological: Cohort B']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C', 'description': 'NSI-8226', 'interventionNames': ['Biological: Cohort C']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D', 'description': 'NSI-8226', 'interventionNames': ['Biological: Cohort D']}], 'interventions': [{'name': 'Cohort A', 'type': 'BIOLOGICAL', 'description': 'Administered IV High dose', 'armGroupLabels': ['Cohort A']}, {'name': 'Cohort B', 'type': 'BIOLOGICAL', 'description': 'Administered SC Low Dose', 'armGroupLabels': ['Cohort B']}, {'name': 'Cohort C', 'type': 'BIOLOGICAL', 'description': 'Administered SC Mid Dose', 'armGroupLabels': ['Cohort C']}, {'name': 'Cohort D', 'type': 'BIOLOGICAL', 'description': 'Administered SC High Dose', 'armGroupLabels': ['Cohort D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Andrew W Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vice President, Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniquity One (UNI)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}