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

Phase 1

Completed

Interventions: Drug: Mirikizumab Prefilled Syringe
Drug: Mirikizumab Autoinjector

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mirikizumab - Prefilled Syringe	Mirikizumab Prefilled Syringe	Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs.
Mirikizumab - Autoinjector	Mirikizumab Autoinjector	Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (3): Covance Dallas
🇺🇸
Dallas, Texas, United States
LabCorp CRU, Inc.
🇺🇸
Daytona Beach, Florida, United States
QPS
🇺🇸
Springfield, Missouri, United States