A Study of LY3471851 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.

Official Title
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A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3471851
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are healthy males or females, as determined by medical history and physical examination Are first generation Japanese or are Caucasian Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening Exclusion Criteria: Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study Have an abnormal blood pressure and/or pulse rate as determined by the investigator Regularly use known drugs of abuse and/or show positive findings on drug screening Are immunocompromised per investigator judgment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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: LY3471851<br>Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC). | Drug: LY3471851<br>* Administered SC<br>* Other names: NKTR-358;|
| Placebo Comparator: Placebo<br>Placebo matching LY3471851 administered SC. | Drug: Placebo<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 | Baseline through Study Completion (up to week 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | PK: AUC of LY3471851 | Predose on Day 1 through Day 50 | 
| PK: Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Predose on Day 1 through Day 50 |