A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

Study Overview
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Brief Summary
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The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.

Official Title
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A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3375880
* Drug: Buffer Matrix (No LY3375880)
* Device: Autoinjector (AI)
* Device: Manual Syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive Females who are not of child-bearing potential Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880 Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy Have participated or are currently enrolled in clinical trials with LY3375880 Have infections or evidence of infections Are pregnant, lactating or breast feeding

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
Interventional Model Description: Part A is a crossover design. Part B is a parallel design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: LY3375880 Formulation A<br>LY3375880 Formulation A administered subcutaneously (SC). | Drug: LY3375880<br>* Administered SC<br>Device: Autoinjector (AI)<br>* AI used to administer LY3375880 or Buffer Matrix<br>|
| Experimental: Part A: LY3375880 Formulation B<br>LY3375880 Formulation B administered subcutaneously SC. | Drug: LY3375880<br>* Administered SC<br>Device: Autoinjector (AI)<br>* AI used to administer LY3375880 or Buffer Matrix<br>|
| Experimental: Part A: LY3375880 Formulation C<br>LY3375880 Formulation C administered SC. | Drug: LY3375880<br>* Administered SC<br>Device: Autoinjector (AI)<br>* AI used to administer LY3375880 or Buffer Matrix<br>|
| Placebo Comparator: Part A: Positive Control<br>Positive Control (buffer matrix, only) administered SC. | Drug: Buffer Matrix (No LY3375880)<br>* Administered SC<br>Device: Autoinjector (AI)<br>* AI used to administer LY3375880 or Buffer Matrix<br>|
| Experimental: Part B: LY3375880 Test 1<br>LY3375880 Test 1 Formulation administered SC. | Drug: LY3375880<br>* Administered SC<br>Device: Manual Syringe<br>* Manual syringe used to inject LY3375880<br>|
| Experimental: Part B: LY3375880 Test 2<br>LY3375880 Test 2 Formulation administered SC. | Drug: LY3375880<br>* Administered SC<br>Device: Manual Syringe<br>* Manual syringe used to inject LY3375880<br>|
| Experimental: Part B: LY3375880 Test 3<br>LY3375880 Test 3 Formulation administered SC. | Drug: LY3375880<br>* Administered SC<br>Device: Manual Syringe<br>* Manual syringe used to inject LY3375880<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). | Part A: Within 1-minute post injection | 
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880 | PK: Cmax of LY3375880 | Part B: Predose through Day 85 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880 | PK: AUC of LY3375880 | Part B: Predose through Day 85 |