A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
NCT ID: NCT05644353
Last Updated: 2025-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
450 participants
INTERVENTIONAL
2022-12-05
2023-05-25
Brief Summary
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Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Mirikizumab
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) to abdomen or arms or thighs on Day 1.
Mirikizumab
Administered SC.
Citrate-Free Mirikizumab
Participants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
Mirikizumab
Administered SC.
Interventions
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Mirikizumab
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
* Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).
Exclusion Criteria
* Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
* Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
* Are lactating or pregnant
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Altasciences Clinical Los Angeles, Inc
Cypress, California, United States
LabCorp CRU, Inc.
Daytona Beach, Florida, United States
Clinical Pharmacology of Miami
Miami, Florida, United States
Qps-Mra, Llc
Miami, Florida, United States
Axis
Dilworth, Minnesota, United States
Labcorp Clinical Research LP
Dallas, Texas, United States
Countries
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References
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Otani Y, Feagan BG, D'Haens GR, Escobar R, Morris NJ, Payne CD, Ugolini Lopes M, Zhang X. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025 May;42(5):2369-2384. doi: 10.1007/s12325-025-03158-y. Epub 2025 Mar 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I6T-MC-AMBY
Identifier Type: OTHER
Identifier Source: secondary_id
17773
Identifier Type: -
Identifier Source: org_study_id
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