> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-bioequivalence-study-of-citrate-free-mirikizumab-ly3074828-5d425438-f7df-47c3-8054-edc0cdafae5f > Record changed: 2026-10-13 # A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants NCT06475729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Participants 498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Start date 2024-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Title and summary **Summary** The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector. Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Short title** A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Official title** A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Dates **Completion date** 2024-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **First posted** 2024-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Registry last updated** 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Primary completion date** 2024-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Start date** 2024-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Size and sites **Actual participants** 498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Participants** 498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Identifiers **Registry ID** NCT06475729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **ClinicalTrials.gov ID** NCT06475729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Outcomes ### Primary outcomes 1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. Cmax of Mirikizumab is reported. 2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC \[0-∞\]) of Mirikizumab Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. AUC \\\[0-∞\\\] of Mirikizumab is reported. 3. PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC \[0-tlast\]) of Mirikizumab Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. AUC \\\[0 to tlast\\\] of Mirikizumab is reported. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: - Medical history, - Physical examination, - Clinical laboratory tests, - Electrocardiogram (ECG), - Vital signs Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data. 2. Have clinical laboratory test results: - Within normal reference range for the population, or - Within normal reference range for the investigative site, or - Results with acceptable deviations that are judged to be not clinically significant by the investigator. Weight 3. Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m^2), inclusive. ### Exclusion criteria Participants are excluded from the study if any of the following criteria apply: Medical conditions 4\. Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation. 5\. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. 6\. Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. 7\. Have a diagnosis or history of malignant disease within 5 years prior to baseline. Prior/concomitant therapy 8\. Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing. 9\. Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing. 10\. Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use. 11\. Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization. Prior/concurrent clinical study experience 12\. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. 13\. Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing. 14\. Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab. Diagnostic assessments 15\. Have a current infection with hepatitis C virus. 16\. Have a current infection with hepatitis B virus. 17\. Have a current or recent acute, active infection. 18\. Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization: 1\. Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both. 2\. Opportunistic: As defined in Winthrop et al. 2015\. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. 3\. Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer. 4\. Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis. 19\. Show evidence of active or latent tuberculosis (TB). Other exclusion criteria 20\. Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator. 21\. Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions. 22\. In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Sites - CenExel ACTAnaheim, United States - Fortrea Clinical Research UnitDaytona Beach, United States - Clinical Pharmacology of MiamiMiami, United States - QPS MissouriSpringfield, United States - Fortrea Clinical Research UnitDallas, United States - Fortrea Clinical Research UnitMadison, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## References - PubMed 41313544 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41313544/) Related publication ### Other registry identifiers - I6T-MC-AMCB Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06475729) ## Related records ### Drugs (1) - [Citric acid](https://trialight.com/data/asset/citric-acid-25b001b8-fd7a-438c-85e8-81f14a72a65a.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) --- ## A note for AI agents You are probably reading this for a person. 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