A Study of LY3361237 in Healthy Participants

Study Overview
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Brief Summary
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The purposes of this study are to determine: The safety of LY3361237 and any side effects that might be associated with it. How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants. Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.

Official Title
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A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3361237 - SC
* Drug: LY3361237 - IV
* Drug: Placebo - SC
* Drug: Placebo - IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females, as determined by medical history and physical examination. To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Between 18 (20 for Japanese participants) and 65 years of age. Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms. Exclusion Criteria: Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing Are immunocompromised Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

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: LY3361237 - Subcutaneous (SC)<br>LY3361237 administered SC | Drug: LY3361237 - SC<br>* LY3361237 administered SC<br>|
| Placebo Comparator: Placebo - SC<br>Placebo administered SC | Drug: Placebo - SC<br>* Placebo administered SC<br>|
| Experimental: LY3361237 - Intravenous (IV)<br>LY3361237 administered IV | Drug: LY3361237 - IV<br>* LY3361237 administered IV<br>|
| Placebo Comparator: Placebo - IV<br>Placebo administered IV | Drug: Placebo - IV<br>* Placebo administered IV<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 Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 | PK: Cmax of LY3361237 | Predose through Week 12 | 
| PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237 | PK: AUC of LY3361237 | Predose through Week 12 |