Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT06672718
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SPY002-091 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent adverse events', 'timeFrame': 'Up to 40 weeks', 'description': 'Incidence, severity, and causal relationship of TEAEs'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 40 weeks', 'description': 'Maximum concentration after single ascending doses'}, {'measure': 'Tmax', 'timeFrame': 'Up to 40 weeks', 'description': 'Time to reach maximum concentration after single ascending doses'}, {'measure': 'AUC', 'timeFrame': 'Up to 40 weeks', 'description': 'Area under the curve after single ascending doses'}, {'measure': 't1/2', 'timeFrame': 'Up to 40 weeks', 'description': 'Half life after single ascending doses'}, {'measure': 'ADA', 'timeFrame': 'Up to 40 weeks', 'description': 'Incidence of anti-drug antibody after single ascending doses'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits\n\nExclusion Criteria:\n\n* Participation in more than one cohort\n* Evidence of clinically significant abnormality or disease\n* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug\n* History of severe allergic reactions or hypersensitivity\n* Donation or loss of \\>1 unit of whole blood within 1 month prior to dosing'}, 'identificationModule': {'nctId': 'NCT06672718', 'briefTitle': 'A Study of SPY002-091 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spyre Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-091 in Healthy Participants', 'orgStudyIdInfo': {'id': 'SPY002-091-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD Cohorts, Experimental Arm', 'description': 'Participants will receive a single dose of SPY002-091 in a dose escalation format', 'interventionNames': ['Drug: SPY002-091']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SAD Cohorts, Placebo Arm', 'description': 'Participants will receive a single dose of placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'SPY002-091', 'type': 'DRUG', 'otherNames': ['SPY002'], 'description': 'Experimental', 'armGroupLabels': ['SAD Cohorts, Experimental Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['SAD Cohorts, Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sammy Armado', 'role': 'CONTACT', 'email': 'sarmado@altasciences.com', 'phone': '714-252-0700', 'phoneExt': '1092'}], 'facility': 'Spyre Site 1', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'centralContacts': [{'name': 'Medical Director, Clinical Development', 'role': 'CONTACT', 'email': 'Spyre_SPY002-091-101@spyre.com', 'phone': '617-651-5940'}], 'overallOfficials': [{'name': 'Joshua Friedman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spyre Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spyre Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Altasciences Company Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}