Study of LY3074828 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo (dummy drug). The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.

Official Title
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A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3074828
* Drug: Placebo
* Drug: LY900021


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Have venous access sufficient to allow for blood sampling and administration of investigational product Exclusion Criteria: Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per 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 1 month of screening or intend to receive during the study Must not be immunocompromised Must not have known hypersensitivity to hyaluronidases 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 dosing Must not have significant allergies to humanized monoclonal antibodies Must not have clinically significant multiple or severe drug allergies, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Part A: Placebo<br>Placebo administered subcutaneously (SC) | Drug: Placebo<br>* Administered SC<br>|
| Experimental: Part A: LY3074828<br>LY3074828 administered SC | Drug: LY3074828<br>* Administered SC<br>|
| Placebo Comparator: Part B: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered SC<br>|
| Experimental: Part B: LY3074828<br>LY3074828 administered SC | Drug: LY3074828<br>* Administered SC<br>|
| Experimental: Part B: LY900021<br>LY900021 (LY3074828 + LY9999QS) administered SC | Drug: LY900021<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Score | The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain). | Within 1-minute post injection |