A Study of Mirikizumab (LY3074828) in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2018-10-24

Brief Summary

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The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.

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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 IV

Participants received 200mg Mirikizumab by intravenously.

Group Type EXPERIMENTAL

Mirikizumab - IV

Intervention Type DRUG

Administered IV

Mirikizumab SC

Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously.

Group Type EXPERIMENTAL

Mirikizumab - SC

Intervention Type DRUG

Administered SC

Placebo IV

Participants received placebo by intravenously.

Group Type PLACEBO_COMPARATOR

Placebo - IV

Intervention Type DRUG

Administered IV

Placebo SC

Participants received placebo by subcutaneously.

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Administered SC

Interventions

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Mirikizumab - IV

Administered IV

Intervention Type DRUG

Mirikizumab - SC

Administered SC

Intervention Type DRUG

Placebo - IV

Administered IV

Intervention Type DRUG

Placebo - SC

Administered SC

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 females, as determined by medical history and physical examination.
* Are first generation Japanese or are Caucasian.
* Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
* Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Exclusion Criteria

* Have had symptomatic herpes zoster within 3 months of screening.
* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
* Have received live vaccine(s) within 1 month of screening or intend to during the study.
* Are immunocompromised.
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes