A Study of Injections of LY3074828 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.

Official Title
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A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 1-mL Autoinjector in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3074828
* Device: PFS
* Device: AI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Must be healthy males or females 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 significant allergies to humanised monoclonal antibodies Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prefilled Syringe (PFS) with LY3074828<br>PFSs containing LY3074828 | Drug: LY3074828<br>* Administered subcutaneously (SC)<br>Device: PFS<br>* PFS used to administer LY3074828<br>|
| Experimental: AutoInjector (AI) with LY3074828<br>AI containing LY3074828 | Drug: LY3074828<br>* Administered subcutaneously (SC)<br>Device: AI<br>* AI used to administer LY3074828<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | PK: Cmax of LY3074828 | Baseline through Day 85 | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t, where t is the Last Sample with a Measurable Concentration | PK: AUC(0-tlast) | Baseline through Day 85 | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3074828 | PK: AUC(0-∞) | Baseline through Day 85 | 
| 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 horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain) | Day 1: Within 1 minute post dose |