A 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 look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828, when given as a solution formulation in different devices. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.

Official Title
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A Safety, Tolerability, and Pharmacokinetic Study of 1- and 2-mL Injections of LY3074828 Solution Using Investigational Pre-filled Syringes and Investigational Autoinjectors in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: LY3074828


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Must be healthy male or female 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 1 month 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: LY3074828 Formulation A<br>LY3074828 solution formulation in two prefilled syringes, administered as subcutaneous (SC) injection | Biological: LY3074828<br>* Administered SC<br>|
| Experimental: LY3074828 Formulation B<br>LY3074828 solution formulation in a prefilled syringe, administered as a SC injection | Biological: LY3074828<br>* Administered SC<br>|
| Experimental: LY3074828 Formulation C<br>LY3074828 solution formulation in an auto-injector | Biological: LY3074828<br>* Administered SC<br>|
| Experimental: LY3074828 Formulation D<br>LY3074828 solution formulation in an auto-injector | Biological: LY3074828<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 (Part A) | PK: Cmax of LY3074828 (Part A) | Baseline through Day 85 (Part A) | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3074828 (Part A) | PK: AUC of LY3074828 (Part A) | Baseline through Day 85 (Part A) | 
| Short Form McGill Pain Questionnaire (SF-MPQ) Total Score | SF-MPQ Total Score | Day 1, 0 hour |