A Study of LY3478006 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.

Official Title
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A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3478006 - IV
* Drug: LY3478006 - SC
* Drug: Placebo - IV
* Drug: Placebo - SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination Women not of childbearing potential Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening Exclusion Criteria: Have clinically significant abnormal electrocardiogram (ECG) results Have persistent abnormal blood pressure or pulse rate, as determined by the investigator Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg) or ≥10 mmHg, respectively Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy Have significant allergies to humanized monoclonal antibodies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: 10 milligram (mg) LY3478006 - Intravenous (IV)<br>Participants received single dose of 10 mg LY3478006 administered IV. Due to early termination of the study Cohort 2 to 6 (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg LY3478006 IV) were not explored for safety reasons following dosing of the first 4 participants in Cohort 1. | Drug: LY3478006 - IV<br>* Administered IV<br>|
| Placebo Comparator: Placebo - IV<br>Participants received single dose of placebo administered IV. Placebo IV Cohorts 2 through 6 were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. | Drug: Placebo - IV<br>* Administered IV<br>|
| Experimental: 100 mg LY3478006 - Subcutaneous (SC) (Cohort 7)<br>100 mg LY3478006 cohort 7 SC dose was not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. | Drug: LY3478006 - SC<br>* Administered SC<br>|
| Placebo Comparator: Placebo - SC (Cohort 7)<br>Placebo cohort 7 SC dose were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. | 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 | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | Baseline through study completion (up to 109 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 | Cmax of LY3478006 was evaluated. | Predose; Day 1 with end of infusion, 3, 6, 12 hours | 
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006 | AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL). | Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85 |