Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 7:07 AM
Study NCT ID:
NCT03267732
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters, Cmax', 'timeFrame': '43 days', 'description': 'maximal plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetic parameters, Tmax', 'timeFrame': '43 days', 'description': 'maximal concentration (Tmax)'}, {'measure': 'Pharmacokinetic parameters, AUC', 'timeFrame': '43 days', 'description': 'area under the plasma concentration curve (AUC)'}, {'measure': 'Pharmacokinetic parameters, CL/F', 'timeFrame': '43 days', 'description': 'clearance (CL/F).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': '43 days', 'description': 'Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Subjects']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.', 'detailedDescription': 'This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between 18 and 55 years of age, inclusive\n2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening\n3. Must be HIV negative by HIV 1/0/2 testing\n4. Must be Hepatitis B (HBV) surface antigen negative\n5. Must be Hepatitis C (HCV) antibody negative\n6. Females must have a negative serum pregnancy test\n7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug\n\nExclusion Criteria:\n\n1. Pregnant or lactating subjects\n2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing\n3. Have poor venous access and are unable to donate blood\n4. Have been vaccinated within 90 days of study dosing\n5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance\n6. Have history of significant drug sensitivity or drug allergy.'}, 'identificationModule': {'nctId': 'NCT03267732', 'acronym': 'Willow 1', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '17297'}, 'secondaryIdInfos': [{'id': 'J1L-AM-JZGE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'AM0010-801', 'type': 'OTHER', 'domain': 'ARMO BioSciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ', 'interventionNames': ['Biological: Pegilodecakin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ', 'interventionNames': ['Biological: Pegilodecakin']}], 'interventions': [{'name': 'Pegilodecakin', 'type': 'BIOLOGICAL', 'otherNames': ['LY3500518', 'AM0010'], 'description': 'Pegilodecakin Alone', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Development', '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'}}}}