Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 6:05 AM
Study NCT ID:
NCT05018403
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects
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'], 'maskingDescription': 'Quadruple: Participant, Investigator, Outcomes Assessor and Care provider.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Five groups of participants will be assigned to receive AON-D21 or placebo in ascending dose order. Doses will be escalated based on safety and pharmacokinetic data.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacodynamics', 'timeFrame': '14 days', 'description': 'To determine the C5a inhibition capacity of AON-D21 by measuring active C5a in blood using a cell-based assay.'}, {'measure': 'Effects on the complement status', 'timeFrame': '14 days', 'description': 'Determining the effect of AON-D21 on levels of C5, C5a, C5b-9 in blood and on the capacity of terminal complement complex formation.'}, {'measure': 'To assess potential for immunogenicity of AON-D21', 'timeFrame': '14 days', 'description': 'Determining the presence of anti-drug antibodies (ADA) and anti-peg antibodies in serum.'}], 'primaryOutcomes': [{'measure': 'Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE.', 'timeFrame': '14 days.', 'description': 'To determine the overall safety and tolerability of AON-D21 by analyzing number of participants with treatment-related adverse events as assessed by CTCAE. Nature, occurrence, and severity of treatment-emergent adverse events.'}, {'measure': 'Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.', 'timeFrame': '14 days', 'description': 'Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE per dosing cohort.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the area under the concentration (AUC)-time curve from 0 to 48 h (AUC0-48).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the area under the concentration (AUC)-time curve from 0 to 72 h (AUC0-72).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the area under the concentration (AUC)-time curve from 0 to infinity (AUC0-inf).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the maximum concentration (Cmax).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the time of maximum concentration (Tmax).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the half-life (t1/2).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the plasma clearance (CL) calculated as Dose/AUC0-inf.'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the volume of distribution (Vz).'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the amount of AON-D21 excreted (Ae) in urine.'}, {'measure': 'Pharmacokinetics of AON-D21.', 'timeFrame': '14 days.', 'description': 'To determine the renal clearance (CLR) of AON-D21.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.', 'detailedDescription': 'This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.\n* Male subjects\n* Subject is healthy as determined by medical evaluation\n* Subject provided written informed consent\n* Subject is willing to comply with all requirements and restrictions according to the study protocol.\n\nExclusion Criteria:\n\n* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.\n* Any acquired or congenital immune deficiency.\n* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).\n* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.\n* Any acquired or congenital immune deficiency.\n* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).\n* Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.\n* Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.\n* Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.\n* Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.\n* Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.\n* Positive drug or alcohol screen at screening and admission.\n* Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.\n* Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last pharmacokinetic (PK) blood sample time point.\n* Legal incapacity or limited legal capacity, or incarceration.\n* Inability to understand or communicate reliably with the Investigator."}, 'identificationModule': {'nctId': 'NCT05018403', 'briefTitle': 'First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aptarion Biotech AG'}, 'officialTitle': 'A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'S-D21-C100'}, 'secondaryIdInfos': [{'id': '2021-000935-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AON-D21', 'description': 'Single ascending doses by iv infusion.', 'interventionNames': ['Drug: Intravenous AON-D21']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo medication identical in appearance to active.', 'interventionNames': ['Drug: Intravenous placebo']}], 'interventions': [{'name': 'Intravenous AON-D21', 'type': 'DRUG', 'otherNames': ['AON-D21'], 'description': 'AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.', 'armGroupLabels': ['AON-D21']}, {'name': 'Intravenous placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Isotonic glucose solution identical in appearance to AON-D21.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89231', 'city': 'Neu-Ulm', 'country': 'Germany', 'facility': 'Nuvisan GmbH', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'Manuela Koch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nuvisan GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aptarion Biotech AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}