A Study of Two Formulations 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 different formulations. 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 study will last about 12 weeks, not including screening.

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 2-mL Autoinjector in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: LY3074828
* Drug: LY3074828
* Device: Auto-injector (AI)
* Device: Prefilled syringe (PFS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3074828 Reference 1<br>Solution formulation in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm | Biological: LY3074828<br>* Administered SC<br>Device: Prefilled syringe (PFS)<br>* PFS to administer LY3074828<br>|
| Experimental: LY3074828 Reference 2<br>Solution formulation in PFS administered as SC injection in thigh | Biological: LY3074828<br>* Administered SC<br>Device: Prefilled syringe (PFS)<br>* PFS to administer LY3074828<br>|
| Experimental: LY3074828 Reference 3<br>Solution formulation in PFS administered as SC injection in abdomen | Biological: LY3074828<br>* Administered SC<br>Device: Prefilled syringe (PFS)<br>* PFS to administer LY3074828<br>|
| Experimental: LY3074828 Test 1<br>Solution formulation administered SC via an auto-injector (AI) in arm | Drug: LY3074828<br>* Administered SC<br>Device: Auto-injector (AI)<br>* AI to administer LY3074828<br>|
| Experimental: LY3074828 Test 2<br>Solution formulation administered SC via an AI in thigh | Drug: LY3074828<br>* Administered SC<br>Device: Auto-injector (AI)<br>* AI to administer LY3074828<br>|
| Experimental: LY3074828 Test 3<br>Solution formulation administered SC via an AI in abdomen | Drug: LY3074828<br>* Administered SC<br>Device: Auto-injector (AI)<br>* AI to administer LY3074828<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 | Pharmacokinetics: Cmax of LY3074828 | Baseline through Day 85 | 
| Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) of LY3074828 | Pharmacokinetics: AUC of LY3074828 | Baseline through Day 85 | 
| Visual Analogue Scale (VAS) Pain Assessment | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. | Day 1, 0 hour |