A Study of Mirikizumab in Healthy Chinese Participants
Condition: Healthy
Intervention: Mirikizumab - IV; Mirikizumab - SC; Placebo - IV; Placebo - SC
Intervention description: Administered IV; Administered SC; Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety of the study drug known as
      mirikizumab. The study will investigate how the body processes the study drug. It will last
      up to about 4 months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Native Chinese (all 4 biological grandparents and both biological parents to be
             Chinese origin)

          -  Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²),
             inclusive, at time of screening

          -  Have clinical laboratory test results within normal reference range for the
             investigative site or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

          -  Have venous access sufficient to allow for blood sampling and administration of
             investigational product (IP) or placebo

          -  Are reliable and willing to be available for the duration of the study and are willing
             to follow study procedures

          -  Are able and willing to give signed informed consent

        Exclusion Criteria:

          -  Are currently enrolled in a clinical study involving an IP or any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Have participated in a clinical trial involving an IP within 30 days or 5 half-lives
             (whichever is longer) prior to screening. If the clinical trial involved treatment
             with biologic agents (such as monoclonal antibodies, including marketed drugs), at
             least 3 months or 5 half-lives (whichever is longer) should have elapsed prior to Day
             1

          -  Have known allergies to LY3074828, humanized monoclonal antibodies, related compounds
             or any components of the formulation, or history of significant atopy

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen or positive
             hepatitis B core antibody

          -  Have had symptomatic herpes zoster within 3 months of screening

          -  Show evidence of active or latent tuberculosis (TB), as documented by medical history,
             examination, chest X-rays (posterior/anterior and lateral), and TB testing (positive
             or indeterminate for QuantiFERON® -TB Gold test or T-Spot. 1 retest permitted
             following indeterminate result); or have had household contact with a person with
             active TB, unless appropriate and documented prophylaxis treatment has been given.
             Participants with any history of active TB are excluded from the study, regardless of
             previous or current TB treatments.

          -  Have received live vaccine(s), including attenuated live vaccines and those
             administered intranasally, within 8 weeks of screening, or intend to during the study

          -  Are immunocompromised

          -  Have clinically significant multiple or severe drug allergies, or intolerance to
             topical corticosteroids, or severe post treatment hypersensitivity reactions
             (including, but not limited to, erythema multiforme major, linear immunoglobulin A
             dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)