Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT04194892
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632591', 'term': 'pegilodecakin'}, {'id': 'C000622455', 'term': 'AM0010'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin', 'timeFrame': 'Predose through approximately 14 days postdose', 'description': 'Cmax of Pegilodecakin'}, {'measure': 'PK: Time of Maximum Concentration (Tmax)', 'timeFrame': 'Predose through approximately 14 days postdose', 'description': 'Tmax of Pegilodecakin'}, {'measure': 'PK: Area Under the Serum Concentration Versus Time Curve (AUC)', 'timeFrame': 'Predose through approximately 14 days postdose', 'description': 'AUC of Pegilodecakin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening\n* Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing.\n* Must be Hepatitis B (HBV) surface antigen negative\n* Must be Hepatitis C (HCV) antibody negative\n* Females must have a negative serum pregnancy test\n\nExclusion Criteria:\n\n* Pregnant or lactating subjects\n* Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing\n* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance\n* Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing\n* Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)\n* Have been vaccinated within 90 days of study dosing'}, 'identificationModule': {'nctId': 'NCT04194892', 'acronym': 'Willow 3', 'briefTitle': 'A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '17299'}, 'secondaryIdInfos': [{'id': 'J1L-AM-JZGG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'AM0010-803', 'type': 'OTHER', 'domain': 'ARMO BioSciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegilodecakin Vial', 'description': 'Pegilodecakin administered subcutaneously (SQ) in one of two study periods.', 'interventionNames': ['Biological: Pegilodecakin']}, {'type': 'EXPERIMENTAL', 'label': 'Pegilodecakin Pre-filled syringe (PFS)', 'description': 'Pegilodecakin administered SQ in one of two study periods.', 'interventionNames': ['Biological: Pegilodecakin']}], 'interventions': [{'name': 'Pegilodecakin', 'type': 'BIOLOGICAL', 'otherNames': ['LY3500518', 'AM0010'], 'description': 'Administered SQ', 'armGroupLabels': ['Pegilodecakin Pre-filled syringe (PFS)', 'Pegilodecakin Vial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Phase 1 Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ARMO BioSciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}