A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate 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 pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. 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.

Official Title
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A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using Investigational 1-mL and 2-mL Prefilled Syringes and Mirikizumab Test Solution Formulation Using Investigational 1-mL and 2-mL Prefilled Syringes in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation 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 significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy 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

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: Single


Arms and Interventions

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