Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 1:15 PM
Study NCT ID:
NCT04607733
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Mirikizumab in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708407', 'term': 'mirikizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up To 85 Days', 'description': 'All participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'AI (Test) Abdomen', 'description': 'AI (Test) Abdomen:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 7, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AI (Test) Arm', 'description': 'AI (Test) Arm:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 6, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AI (Test) Thigh', 'description': 'AI (Test) Thigh:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 8, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PFS (Reference) Abdomen', 'description': 'PFS (Reference) Abdomen:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 6, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PFS (Reference) Arm', 'description': 'PFS (Reference) Arm:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 5, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PFS (Reference) Thigh', 'description': 'PFS (Reference) Thigh:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 6, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFS (Reference)', 'description': 'PFS (Reference):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'OG001', 'title': 'AI (Test)', 'description': 'AI (Test):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '44', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: Cmax of Mirikizumab', 'unitOfMeasure': 'micrograms/milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFS (Reference)', 'description': 'PFS (Reference):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'OG001', 'title': 'AI (Test)', 'description': 'AI (Test):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'spread': '44', 'groupId': 'OG000'}, {'value': '262', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: AUC\\[0-∞\\] of Mirikizumab', 'unitOfMeasure': 'micrograms*day/milliliter (µg*day/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFS (Reference)', 'description': 'PFS (Reference):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'OG001', 'title': 'AI (Test)', 'description': 'AI (Test):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'spread': '44', 'groupId': 'OG000'}, {'value': '257', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: AUC\\[0-tlast\\] of Mirikizumab', 'unitOfMeasure': 'micrograms*day/milliliter (µg*day/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AI (Test) Abdomen', 'description': 'AI (Test) Abdomen:\n\n2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}, {'id': 'FG001', 'title': 'AI (Test) Arm', 'description': 'AI (Test) Arm:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}, {'id': 'FG002', 'title': 'AI (Test) Thigh', 'description': 'AI (Test) Thigh:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}, {'id': 'FG003', 'title': 'PFS (Reference) Abdomen', 'description': 'PFS (Reference) Abdomen:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'FG004', 'title': 'PFS (Reference) Arm', 'description': 'PFS (Reference) Arm:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'FG005', 'title': 'PFS (Reference) Thigh', 'description': 'PFS (Reference) Thigh:\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '39'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AI (Test)', 'description': 'AI (Test):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).'}, {'id': 'BG001', 'title': 'PFS (Reference)', 'description': 'PFS (Reference):\n\n2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 1177902, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-05T21:20', 'hasProtocol': True}, {'date': '2020-10-19', 'size': 1741647, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-05T21:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2020-10-28', 'resultsFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-16', 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: Cmax of Mirikizumab'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: AUC\\[0-∞\\] of Mirikizumab'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab', 'timeFrame': 'Predose up to 85 days postdose', 'description': 'PK: AUC\\[0-tlast\\] of Mirikizumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40900263', 'type': 'DERIVED', 'citation': 'Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.\n\nScreening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females, as determined through medical history and physical examination\n\nExclusion Criteria:\n\n* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)\n* Must not show evidence of active or latent tuberculosis (TB)\n* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study\n* Must not have been treated with steroids within 1 month of screening, or intend to during the study\n* Must not be immunocompromised\n* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1\n* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions\n* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Must not have had breast cancer within the past 10 years\n* Must not have significant allergies to humanized monoclonal antibodies'}, 'identificationModule': {'nctId': 'NCT04607733', 'briefTitle': 'A Study of Mirikizumab in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants', 'orgStudyIdInfo': {'id': '17820'}, 'secondaryIdInfos': [{'id': 'I6T-MC-AMBW', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirikizumab - Prefilled Syringe', 'description': '2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)', 'interventionNames': ['Drug: Mirikizumab Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab - Autoinjector', 'description': '2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)', 'interventionNames': ['Drug: Mirikizumab Autoinjector']}], 'interventions': [{'name': 'Mirikizumab Prefilled Syringe', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered SC by prefilled syringe', 'armGroupLabels': ['Mirikizumab - Prefilled Syringe']}, {'name': 'Mirikizumab Autoinjector', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered SC by autoinjector', 'armGroupLabels': ['Mirikizumab - Autoinjector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'QPS', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}