Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT02648269
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity', 'timeFrame': '30 days', 'description': 'To assess the safety and tolerability of a single infusion of SEL-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of SEL-110 (AUC)', 'timeFrame': '30 days', 'description': 'Measurement of the pharmacokinetics of SEL-110 over 30 days by area under the blood concentration versus time curve (AUC)'}, {'measure': 'Pharmacokinetics of SEL-037 (AUC)', 'timeFrame': '30 days', 'description': 'Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)'}, {'measure': 'Pharmacodynamics of SEL-037 (blood uric acid levels)', 'timeFrame': '30 days', 'description': 'Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days'}, {'measure': 'Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)', 'timeFrame': '30 days', 'description': 'Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gout']}, 'referencesModule': {'references': [{'pmid': '35022448', 'type': 'DERIVED', 'citation': 'Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.'}]}, 'descriptionModule': {'briefSummary': 'This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.', 'detailedDescription': 'This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single, ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects ages 21 to 70 inclusive. Female subjects must be of non-childbearing potential;\n* Has at the screening visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;\n* The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the screening visit;\n* Has adequate venous access and able to receive IV therapy;\n* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;\n\nExclusion Criteria:\n\n* Prior exposure to any experimental or marketed uricase (for arms receiving SEL-037 or SEL-212);\n* History of any allergy to pegylated products;\n* Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;\n* History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;\n* Presently taking a drug classified as CYP3A4 inducer or inhibitor;\n* Has participated in a clinical trial within 30 days of the Screening;'}, 'identificationModule': {'nctId': 'NCT02648269', 'briefTitle': 'Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Selecta Biosciences, Inc.'}, 'officialTitle': 'A Phase I Single Ascending Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 in Subjects With Elevated Blood Uric Acid', 'orgStudyIdInfo': {'id': 'SEL-212/101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEL-110', 'description': 'Single intravenous dose of SEL-110', 'interventionNames': ['Drug: SEL-110', 'Biological: SEL-212']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212', 'description': 'Single intravenous dose of SEL-110 plus SEL-037 (pegsiticase)', 'interventionNames': ['Biological: SEL-212']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-037', 'description': 'Single intravenous dose of SEL-037 (pegsiticase)', 'interventionNames': ['Biological: SEL-037']}], 'interventions': [{'name': 'SEL-110', 'type': 'DRUG', 'armGroupLabels': ['SEL-110']}, {'name': 'SEL-212', 'type': 'BIOLOGICAL', 'armGroupLabels': ['SEL-110', 'SEL-212']}, {'name': 'SEL-037', 'type': 'BIOLOGICAL', 'armGroupLabels': ['SEL-037']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Health Center for Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SNBL Clinical Pharmacology Center Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Davita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clincal Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selecta Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}