A Study of LY3876602 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 and tolerability of LY3876602 after administering as single ascending doses and following a data review proceeding to multiple ascending doses in healthy participants. The blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it. The study will last up to approximately 17 weeks. A subgroup of participants will be consented for CSF collections.

Official Title
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A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3876602
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants who are overtly healthy as determined by medical evaluation Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²) Male or female participants of nonchildbearing potential Exclusion Criteria: Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders Have allergies to diphenhydramine, epinephrine, or methylprednisolone Have serious or unstable medical conditions, History of skin wounding within 14 days of screening or current skin infection Are unwilling to stop alcohol consumption 48 hours prior to each dosing Have active or latent tuberculosis Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics

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: LY3876602<br>Single ascending doses of LY3876602 administered intravenously (IV). | Drug: LY3876602<br>* Administered IV.<br>|
| Placebo Comparator: Placebo<br>Placebo administered IV. | Drug: Placebo<br>* Administered IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602 | PK: AUC of LY3876602 | Predose up to 17 weeks | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3876602 | PK: Cmax of LY3876602 | Predose up to 17 weeks | 
| PK: Half-life (t1/2) of LY3876602 | PK: t1/2 of LY3876602 | Predose up to 17 weeks |