A Study of LY3053102 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Official Title
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A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY3053102
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal blood pressure Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening Exclusion Criteria: Had known allergies to LY3053102 or related compounds Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids Heavy smokers (more than 10 cigarettes a day)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3053102<br>A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level. | Drug: LY3053102<br> <br> |
| Placebo Comparator: Placebo<br>A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks. | Drug: Placebo<br> <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 Adverse Events (AEs) or Any Serious AEs | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through Day 31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | AUC curve from time 0 to 168 hours postdose of LY3053102. | Time 0 to 168 hours after study drug administration on Day 1 | 
| PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1. | Time 0 to 168 hours after study drug administration on Day 1 | 
| Number of Participants Who Developed Anti-LY3053102 Antibodies | LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized. | Baseline, up to Day 31 |