A Study of LY3375880 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm. This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.

Official Title
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A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3375880 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3375880 IV
* Drug: LY3375880 SC
* Drug: Placebo IV
* Drug: Placebo SC


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 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 Are women who are of childbearing potential or who are lactating

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3375880 Single Dose<br>Single dose of LY3375880 administered IV or SC | Drug: LY3375880 IV<br>* administered IV<br>Drug: LY3375880 SC<br>* administered SC<br>|
| Placebo Comparator: Placebo Single Dose<br>Single dose of placebo administered IV or SC | Drug: Placebo IV<br>* administered IV<br>Drug: Placebo SC<br>* administered SC<br>|
| Experimental: LY3375880 Multiple Dose<br>Multiple doses of LY3375880 administered IV or SC | Drug: LY3375880 IV<br>* administered IV<br>Drug: LY3375880 SC<br>* administered SC<br>|
| Placebo Comparator: Placebo Multiple Dose<br>Multiple doses of placebo administered IV or SC | Drug: Placebo IV<br>* administered IV<br>Drug: Placebo SC<br>* administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Pre-dose to 3 months after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880 | PK: Cmax of LY3375880 | Pre-dose to 3 months after administration of study drug | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880 | PK: AUC of LY3375880 | Pre-dose to 3 months after administration of study drug |