A Safety Study of Mirikizumab (LY3074828)

Study Overview
=================
Brief 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 and how the drug affects the body. The study will last about 3 months for each participant.

Official Title
-----------------
A Phase I, Randomized, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Biological: Mirikizumab- IV
* Biological: Mirikizumab - SC
* Biological: Placebo - IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Psoriasis participants): Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline Plaque psoriasis involving >2% body surface area (BSA) in affected skin other than the face and scalp at screening and baseline Are willing and able to washout topicals for at least 14 days before baseline on the 2 target lesions Inclusion Criteria (Healthy participants): Are overtly healthy males or females, as determined by medical history and physical examination Are women not of childbearing potential Are between the ages of 18 and 65 years, inclusive, at the time of screening Have a body mass index between 18.5 and 32.0 kilogram per square meter (kg/m2), inclusive, and a minimum body weight of 55 kg Have clinical laboratory test results within normal reference range for the central laboratory, or results with acceptable deviations that are judged to be not clinically significant by the investigator Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Have given written informed consent approved by Lilly and the ERB governing the site Exclusion Criteria (Psoriasis and healthy participants): Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy). Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval Within 28 days prior to baseline: have received systemic nonbiologic psoriasis therapy Within 14 days prior to baseline: have received topical psoriasis treatment Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data Have had clinically significant symptomatic herpes zoster within 3 months of screening Show evidence of active or latent tuberculosis (TB) Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study Have significant allergies to humanized monoclonal antibodies or any components of the mirikizumab product formulation or have a history of significant atopy 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 and cervical carcinoma in situ, with no evidence of recurrence within 5 years prior to baseline

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo IV<br>Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV) | Biological: Placebo - IV<br>* Administered IV<br>|
| Experimental: Mirikizumab IV<br>Participants with psoriasis will receive a single escalating dose of 5 milligram (mg), 20 mg, 60 mg, 120 mg, 200 mg, 350 mg, or 600 mg mirikizumab, IV | Biological: Mirikizumab- IV<br>* Administered IV<br>* Other names: LY3074828;|
| Experimental: Mirikizumab SC<br>Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC). | Biological: Mirikizumab - SC<br>* Administered SC<br>* Other names: LY3074828;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline through 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Mirikizumab |  | Baseline through 12 Weeks | 
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Mirikizumab |  | Baseline through 12 Weeks |