Safety Study of LY3041658 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months. Protocol amended in January, 2016 to include first generation Japanese participants.

Official Title
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A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3041658 (SC)
* Drug: LY3041658 (IV)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All: Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²). Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10^3/microliter (uL), inclusive. First-generation Japanese: Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan. Are 20 to 65 years of age, inclusive, at the time of initial screening. Exclusion Criteria: - Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.

Ages Eligible for Study
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Minimum Age: 18 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: LY3041658 (IV)<br>Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts. | Drug: LY3041658 (IV)<br>* Administered as slow IV infusion<br>|
| Experimental: LY3041658 (SC)<br>Single dose of LY3041658 administered subcutaneously (SC). | Drug: LY3041658 (SC)<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion. | Drug: Placebo<br>* Administered as slow IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with One or More Drug-Related Adverse Events |  | Baseline to study completion (Day 85) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658 |  | Predose through Day 85, at specified timepoints | 
| Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast) |  | Predose through Day 85, at specified timepoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune, antibody