Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT05565768
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate HZN-457 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': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).', 'timeFrame': 'Day 1 up to Day 337'}, {'measure': 'Change from Baseline in Hemoglobin value.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in white blood cell counts.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in platelet counts.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Prothrombin Time.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Activated Partial Thromboplastin Time.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Aspartate Aminotransferase (AST) value.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Alanine Aminotransferase (ALT) value.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Urinalysis values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Systolic Blood Pressure values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Pulse Rate values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Respiratory Rate values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in Body Temperature values.', 'timeFrame': 'Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85'}, {'measure': 'Change from Baseline in ECG Heart Rate values.', 'timeFrame': 'Baseline, Day 1 Post-Dose, Day 2, Day 4'}, {'measure': 'Change from Baseline in ECG PR values.', 'timeFrame': 'Baseline, Day 1 Post-Dose, Day 2, Day 4'}, {'measure': 'Change from Baseline in ECG QRS values.', 'timeFrame': 'Baseline, Day 1 Post-Dose, Day 2, Day 4'}, {'measure': 'Change from Baseline in ECG QT values.', 'timeFrame': 'Baseline, Day 1 Post-Dose, Day 2, Day 4'}, {'measure': 'Change from Baseline in ECG QTc values.', 'timeFrame': 'Baseline, Day 1 Post-Dose, Day 2, Day 4'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'Day 1 to Day 8'}, {'measure': 'Time to peak plasma concentration (Tmax)', 'timeFrame': 'Day 1 to Day 8'}, {'measure': 'Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)', 'timeFrame': 'Day 1 to Day 8'}, {'measure': 'Elimination half-life (t1/2)', 'timeFrame': 'Day 1 to Day 8'}, {'measure': 'Fraction of the administered dose excreted into the urine (Fe)', 'timeFrame': 'Day 1 to Day 2'}, {'measure': 'Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing', 'timeFrame': 'Day 1 to Day 337'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Screening serum uric acid (sUA) ≥ 4 mg/dL (238 µmol/L)\n* Screening body mass index (BMI) between 20 to 34.0 kg/m2, inclusive\n* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG findings, as deemed by the Investigator.\n* Male participants must refrain from donating sperm and either agree to remain abstinent from heterosexual intercourse OR agree to utilize contraception\n* Female participants must be non-pregnant, non-lactating postmenopausal woman of non-childbearing potential (WONCBP) with a follicle-stimulating hormone (FSH) level in the postmenopausal range (\\> 40 IU/L)\n\nExclusion Criteria:\n\n* History or presence of gout.\n* Use of any prescription medication within 14 days or 5 half-lives prior to dosing\n* Participation in another investigational clinical study (eg, drug, vaccine, invasive device) within 30 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Current liver disease, as determined by alanine transaminase (ALT) or aspartate transaminase (AST) levels \\> upper limit of normal (ULN) at Screening or Day -1.'}, 'identificationModule': {'nctId': 'NCT05565768', 'briefTitle': 'Study to Evaluate HZN-457 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Horizon Pharma Ireland, Ltd., Dublin Ireland'}, 'officialTitle': 'A Phase 1 Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HZN-457 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HZNP-HZN-457-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HZN-457', 'interventionNames': ['Drug: HZN-457']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HZN-457', 'type': 'DRUG', 'description': 'HZN-457 will be given in one subcutaneous administration', 'armGroupLabels': ['HZN-457']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be given in one subcutaneous administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Horizon Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Horizon Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horizon Therapeutics Ireland DAC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}