A Study to Compare Two Different Formulations of Mirikizumab 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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2021-01-11

Brief Summary

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The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.

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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

DOUBLE

Participants Investigators

Study Groups

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Mirikizumab (Reference)

200 milligram (mg) of mirikizumab as reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Reference and test formulations of mirikizumab administered as a SC injection.

Mirikizumab (Test)

200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Reference and test formulations of mirikizumab administered as a SC injection.

Interventions

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Mirikizumab

Reference and test formulations of mirikizumab administered as a SC injection.

Intervention Type DRUG

Other Intervention Names

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LY3074828

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy males or females, as determined through medical history and physical examination

Exclusion Criteria

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* 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 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
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes