Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
Study NCT ID:
NCT05019950
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
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': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '1 to 14 days'}], 'secondaryOutcomes': [{'measure': 'PK', 'timeFrame': '24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;\n2. Adult males and females, 18 to 64 years of age (inclusive) at screening;\n3. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nKey Exclusion Criteria:\n\n1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;\n2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;\n3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.'}, 'identificationModule': {'nctId': 'NCT05019950', 'briefTitle': 'Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'NImmune Biopharma'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers', 'orgStudyIdInfo': {'id': 'LABP-104-1a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIM-1324', 'description': 'Once daily oral tablet', 'interventionNames': ['Drug: NIM-1324']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily oral tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NIM-1324', 'type': 'DRUG', 'description': 'Once daily oral tablet', 'armGroupLabels': ['NIM-1324']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily oral tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NImmune Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}