Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-21 @ 8:29 PM
Study NCT ID:
NCT05521269
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2022-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Study of ANX1502 in Healthy Volunteers
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', 'interventionModelDescription': 'This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2022-08-28', 'studyFirstSubmitQcDate': '2022-08-28', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Day 1 (after dosing) through Day 29'}], 'secondaryOutcomes': [{'measure': 'Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Predose up Day 29'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Predose up Day 29'}, {'measure': 'Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Predose up to Day 29'}, {'measure': 'Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Predose up Day 29'}, {'measure': 'Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502', 'timeFrame': 'Predose up to Day 29'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['healthy'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.\n* MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.\n\nKey Exclusion Criteria:\n\n* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.\n* History of any autoimmune disease\n* History of meningitis or septicemia\n* Clinically significant infection within 30 days prior to study drug administration that required medical intervention\n* Known genetic deficiencies of the complement cascade system or immunodeficiency.\n* Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.\n* Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .\n* History of prior other malignancy that could affect compliance with the protocol or interpretation of results\n* Has clinically significant laboratory abnormalities or abnormal ECG\n* History of splenectomy.\n* Antinuclear antibodies titer ≥1:160 at Screening.\n* Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.'}, 'identificationModule': {'nctId': 'NCT05521269', 'briefTitle': 'Dose Study of ANX1502 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Annexon, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteer', 'orgStudyIdInfo': {'id': 'ANX1502-NHV-01'}, 'secondaryIdInfos': [{'id': '2022-000594-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANX1502 SAD', 'description': 'Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.', 'interventionNames': ['Drug: ANX1502', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ANX1502 MAD', 'description': 'Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.', 'interventionNames': ['Drug: ANX1502', 'Drug: Placebo']}], 'interventions': [{'name': 'ANX1502', 'type': 'DRUG', 'description': 'ANX1502 is a prodrug of ANX1439.', 'armGroupLabels': ['ANX1502 MAD', 'ANX1502 SAD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator.', 'armGroupLabels': ['ANX1502 MAD', 'ANX1502 SAD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Annexon Investigational Site 01', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Olga Bandman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Annexon, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annexon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}