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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mirikizumab	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.
Citrate-Free Mirikizumab	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation	Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose	PK: Cmax of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation	Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose	PK: AUC\[0-∞\] of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation	Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose	PK: AUC\[0-tlast\] of Mirikizumab

Secondary Outcome Measures

Name	Time	Method

Locations (6): Clinical Pharmacology of Miami
🇺🇸
Miami, Florida, United States
Altasciences Clinical Los Angeles, Inc
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Cypress, California, United States
Qps-Mra, Llc
🇺🇸
Miami, Florida, United States
Labcorp Clinical Research LP
🇺🇸
Dallas, Texas, United States
Axis
🇺🇸
Dilworth, Minnesota, United States
LabCorp CRU, Inc.
🇺🇸
Daytona Beach, Florida, United States