Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04817202
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007279', 'term': 'Injections, Subcutaneous'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline QTc interval at each time point', 'timeFrame': 'Group A1~A7: Day 1 (pre-dose), Day 8, Day 15, Day 22, Day 29, Day 36, Day 50, Day 64, Day 78, Day 92 Group B1~B2: Day 1 (pre-dose), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 98, Day 162', 'description': 'Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100\\~300Hz'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic - Cmax', 'timeFrame': 'Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98', 'description': 'Maximum observed Concentration of hzVSF-v13'}, {'measure': 'Pharmacokinetic - AUC0-∞', 'timeFrame': 'Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98', 'description': 'Area under the plasma concentration-time curve (AUC) from time zero to infinity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.', 'detailedDescription': 'A phase I, double-blind, placebo-controlled, single and multiple dose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.\n* Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).'}, 'identificationModule': {'nctId': 'NCT04817202', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmuneMed, Inc.'}, 'officialTitle': 'hzVSF-v13 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics After Intravenous and Subcutaneous Administration in Healthy Adults', 'orgStudyIdInfo': {'id': 'hzVSF_v13-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A1 (hzVSF-v13 50mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A2 (hzVSF-v13 100mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A3 (hzVSF-v13 200mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A4 (hzVSF-v13 400mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A5 (hzVSF-v13 800mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A6 (hzVSF-v13 1200mg, intravenous, single dose)', 'description': 'Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)', 'description': 'Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.', 'interventionNames': ['Drug: hzVSF-v13 (subcutaneous, single dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)', 'description': 'Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, multiple dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)', 'description': 'Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.', 'interventionNames': ['Drug: hzVSF-v13 (intravenous, multiple dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (intravenous, single dose)', 'description': 'Single administration (intravenous) of placebo on Day 1.', 'interventionNames': ['Drug: Placebo (intravenous, single dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (subcutaneous, single dose)', 'description': 'Single administration (subcutaneous) of placebo on Day 1.', 'interventionNames': ['Drug: Placebo (subcutaneous, single dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (intravenous, multiple dose)', 'description': 'Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.', 'interventionNames': ['Drug: Placebo (intravenous, multiple dose)']}], 'interventions': [{'name': 'hzVSF-v13 (intravenous, single dose)', 'type': 'DRUG', 'otherNames': ['a humanized monoclonal antibody (mAb)'], 'description': 'Dosage form: 50mg / 100mg / 200mg / 400mg / 800mg /1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1 (single administration)', 'armGroupLabels': ['Group A1 (hzVSF-v13 50mg, intravenous, single dose)', 'Group A2 (hzVSF-v13 100mg, intravenous, single dose)', 'Group A3 (hzVSF-v13 200mg, intravenous, single dose)', 'Group A4 (hzVSF-v13 400mg, intravenous, single dose)', 'Group A5 (hzVSF-v13 800mg, intravenous, single dose)', 'Group A6 (hzVSF-v13 1200mg, intravenous, single dose)']}, {'name': 'hzVSF-v13 (subcutaneous, single dose)', 'type': 'DRUG', 'otherNames': ['a humanized monoclonal antibody (mAb)'], 'description': 'Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)', 'armGroupLabels': ['Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)']}, {'name': 'hzVSF-v13 (intravenous, multiple dose)', 'type': 'DRUG', 'otherNames': ['a humanized monoclonal antibody (mAb)'], 'description': 'Dosage form: 100mg / 400mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)', 'armGroupLabels': ['Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)', 'Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)']}, {'name': 'Placebo (intravenous, single dose)', 'type': 'DRUG', 'otherNames': ['0.9% Normal saline'], 'description': 'Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)', 'armGroupLabels': ['Placebo (intravenous, single dose)']}, {'name': 'Placebo (subcutaneous, single dose)', 'type': 'DRUG', 'otherNames': ['0.9% Normal saline'], 'description': 'Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)', 'armGroupLabels': ['Placebo (subcutaneous, single dose)']}, {'name': 'Placebo (intravenous, multiple dose)', 'type': 'DRUG', 'otherNames': ['0.9% Normal saline'], 'description': 'Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)', 'armGroupLabels': ['Placebo (intravenous, multiple dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX, Clinical Research Pty Ltd.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': '+61-8-70887900 Wabnitz, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMAX Clinical Research Pty Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmuneMed, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}