Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 4:42 PM
Study NCT ID:
NCT04829435
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '28 days', 'description': 'Number of of participants with treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Serum ALLN-346', 'timeFrame': '8 days', 'description': 'Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia', 'Gout']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.\n\nALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.', 'detailedDescription': 'This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take place at a clinical pharmacology unit (CPU). Two sequential cohorts will be dosed and followed for safety through Day 28.\n\nThe study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 to 55 years\n* Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation\n* Good general health as determined by medical history and physical examination\n* Normal clinical laboratory test results and ECG\n\nExclusion Criteria:\n\n* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia\n* Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines\n* Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse, or positive COVID-19 test\n* Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)\n* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody\n* Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening\n* Prior dosing in ALLN-346 clinical study\n* Per Investigator judgment, is not an ideal clinical study candidate'}, 'identificationModule': {'nctId': 'NCT04829435', 'acronym': 'MAD', 'briefTitle': 'Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allena Pharmaceuticals'}, 'officialTitle': 'A Phase I Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)', 'orgStudyIdInfo': {'id': 'ALLN-346-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALLN-346 (Engineered Urate Oxidase)', 'description': 'ALLN-346 is novel urate oxidase provided as capsules for oral administration. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.', 'interventionNames': ['Drug: ALLN-346']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsules for oral administration. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALLN-346', 'type': 'DRUG', 'otherNames': ['Engineered urate oxidase'], 'description': 'ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; It is a proprietary enzyme designed to degrade urate in the intestinal tract', 'armGroupLabels': ['ALLN-346 (Engineered Urate Oxidase)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching placebo capsule'], 'description': 'Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Christine Tosone, MS, RAC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allena Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allena Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}