A Study of LY3461767 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

Official Title
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A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3461767 - SC
* Drug: LY3461767 - IV
* Drug: Placebo - SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are healthy males, or females of non-child-bearing potential Have a body mass index of 18 to 35 kilograms per square meter (kg/m²) Have clinical laboratory tests within normal ranges as judged by investigator Have pulse rate and blood pressure within normal ranges as judged by investigator Exclusion Criteria: Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening Have an abnormality in the 12-lead electrocardiogram (ECG) at screening Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders Regularly use known drugs of abuse Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study Smoke more than 10 cigarettes per day Are current or former smokers with 30-pack-year smoking history Have a diagnosis or history of any malignancy Have not had appropriate cancer screening, in accordance with country specific guidance

Ages Eligible for Study
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Minimum Age: 21 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3461767 - Subcutaneous (SC)<br>LY3461767 administered SC. | Drug: LY3461767 - SC<br>* Administered SC.<br>|
| Placebo Comparator: Placebo - SC<br>Placebo administered SC. | Drug: Placebo - SC<br>* Administered SC.<br>|
| Experimental: LY3461767 - Intravenous (IV)<br>LY3461767 administered IV. | Drug: LY3461767 - IV<br>* Administered IV.<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 | Baseline through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767 | PK: Cmax of LY3461767 | Baseline through Day 29 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767 | PK: AUC of LY3461767 | Baseline through Day 29 |