Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-13 @ 4:25 AM
Study NCT ID:
NCT06356259
Status:
TERMINATED
Last Update Posted:
2025-03-26
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'whyStopped': 'The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Serious Adverse Events', 'timeFrame': 'Baseline upto Day 168', 'description': 'Evaluation of Safety and Tolerability of IRX-010'}, {'measure': 'Number of participants with Treatment-Emergent Adverse Events', 'timeFrame': 'Baseline upto Day 168', 'description': 'Evaluation of Safety and Tolerability of IRX-010'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics(PK): Area under Curve(AUC)', 'timeFrame': 'Baseline upto Day 168', 'description': 'PK: AUC of IRX-010'}, {'measure': 'Pharmacokinetics(PK): Maximum Concentration (Cmax)', 'timeFrame': 'Baseline upto Day 168', 'description': 'PK: Cmax of IRX-010'}, {'measure': 'Pharmacokinetics(PK): Half-Life (t½)', 'timeFrame': 'Baseline upto Day 168', 'description': 'PK: t½ of IRX-010'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.', 'detailedDescription': 'This is a single and multiple ascending dose, proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants. Approximately 81 healthy participants will be enrolled in up to 9 cohorts. The study is conducted in two parts (part A and part B) with 6 single ascending dose (Part A - SAD) cohorts of 9 participants per cohort and 3 multiple ascending dose (Part B - MAD) cohorts of 9 participants per cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female participants who are healthy as determined by medical history and physical evaluation.\n* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically. significant by the investigator at screening and enrolment.\n* Have an estimated glomerular filtration rate ≥60 mL/minute/1.73 m2 at screening and enrolment.\n* Have venous access sufficient to allow for blood sampling as per the protocol. Weight\n* Have a body mass index of 18.0 to 32.0 kg/m2 inclusive, at screening.\n\nExclusion Criteria:\n\n* Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, haematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicates a medical problem that would preclude study participation.\n* Have history (within past 5 years) of, or presence of, uncontrolled asthma, significant rheumatological or autoimmune diseases, including but not limited to systemic lupus erythematosus, RA, Sjogren's Syndrome, or vasculitis; or hereditary angioedema, or common variable immune deficiency.\n* Have had lymphoma, leukaemia, or any malignancy within the past 5 years.\n* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (if known) (whichever is longer) prior to dosing\n* Have active or latent Tuberculosis (TB), based on a positive medical history, examination, chest x-rays (as per local TB screening guidelines), and/or TB test results."}, 'identificationModule': {'nctId': 'NCT06356259', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunoRx Pharma Inc.'}, 'officialTitle': 'A Randomised, Placebo-Controlled, Double-blind, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IMMUNRX-01'}, 'secondaryIdInfos': [{'id': '2023-503917-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRX-010 Part A (SAD)', 'description': 'A single dose of IRX-010 will be administered intravenously', 'interventionNames': ['Drug: IRX-010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A (SAD)', 'description': 'Placebo administered intravenously', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IRX-010 Part B(MAD)', 'description': 'Multiple doses of IRX-010 will be administered intravenously', 'interventionNames': ['Drug: IRX-010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B(MAD)', 'description': 'Placebo administered intravenously', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IRX-010', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['IRX-010 Part A (SAD)', 'IRX-010 Part B(MAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Placebo Part A (SAD)', 'Placebo Part B(MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'ICON', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'ImmunoRx Pharma,Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ImmunoRx Pharma Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmunoRx Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}