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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-06-22

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mirikizumab Prefilled Syringe

Intervention Type DRUG

Administered SC by prefilled syringe

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.

Group Type EXPERIMENTAL

Mirikizumab Autoinjector

Intervention Type DRUG

Administered SC by autoinjector

Interventions

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Mirikizumab Prefilled Syringe

Administered SC by prefilled syringe

Intervention Type DRUG

Mirikizumab Autoinjector

Administered SC by autoinjector

Intervention Type DRUG

Other Intervention Names

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LY3074828 LY3074828

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes