A Study of LY3025876 in Healthy Volunteers

Study Overview
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Brief Summary
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This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Official Title
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A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3025876 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY3025876
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be either a healthy male or a healthy female who cannot become pregnant Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening Exclusion Criteria: Are allergic to LY3025876 or related compounds Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication Have 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. Corticosteroids are mainly used to control inflammation.

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>0.9% sodium chloride given as a single subcutaneous injection | Drug: Placebo<br>* Given as a subcutaneous injection<br>|
| Experimental: LY3025876<br>Single escalating doses of LY3025876 given as subcutaneous injections | Drug: LY3025876<br>* Given as a subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module. | Baseline up to 28 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose | 
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 |  | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose | 
| Number of Participants Developing Anti-LY3025876 Antibodies | Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876. | Day 28 post-dose |