A Safety Study of LY3462817 in Healthy Participants

Study Overview
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Brief Summary
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This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.

Official Title
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Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817

Conditions
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Healthy

Intervention / Treatment
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* Biological: LY3462817 IV
* Biological: LY3462817 SC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy male or a female who cannot get pregnant Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study Weight at least 45 kilograms (kg) Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have cancer or a malignant disease in the past 5 years Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study Are unwilling to receive study drug administration by injections or through the veins

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: LY3462817 - IV<br>Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants | Biological: LY3462817 IV<br>* Administered IV<br>|
| Placebo Comparator: Placebo<br>Normal saline administered as a single IV infusion in healthy participants | Drug: Placebo<br>* Administered IV<br>|
| Experimental: LY3462817 - SC<br>Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants | Biological: LY3462817 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through to final follow-up at approximately Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817 | Pharmacokinetics: Cmax of LY3462817 | Baseline through to final follow-up at approximately Week 12 | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817 | Pharmacokinetics: AUC of LY3462817 | Baseline through to final follow-up at approximately Week 12 |