A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

Study Overview
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Brief Summary
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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. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Official Title
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A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mirikizumab Prefilled Syringe
* Drug: Mirikizumab Autoinjector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or non-pregnant females of childbearing or non-childbearing potential Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive) Exclusion Criteria: Must not show evidence of active or latent tuberculosis (TB) 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 Must not have been treated with steroids within 1 month of screening, or intend to during the study Must not have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1 Must not be immunocompromised 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 Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions 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 Must not have had breast cancer within the past 10 years Must not have significant allergies to humanized monoclonal antibodies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab - Prefilled Syringe<br>Mirikizumab administered by subcutaneous injection (SC) via a prefilled syringe (PFS) at 3 different injection sites (arm, thigh, and abdomen). | Drug: Mirikizumab Prefilled Syringe<br>* Administered SC by prefilled syringe<br>* Other names: LY3074828;|
| Experimental: Mirikizumab - Autoinjector<br>Mirikizumab administered by SC via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen). | Drug: Mirikizumab Autoinjector<br>* Administered SC by autoinjector<br>* Other names: LY3074828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab | Predose up to 85 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab | PK: AUC[0-∞] of Mirikizumab | Predose up to 85 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab | PK: AUC[0-tlast] of Mirikizumab | Predose up to 85 days postdose |