Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3462817 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3462817 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 12 weeks.
Interventions
DRUGLY3462817 (SC)
Administered SC.
DRUGPlacebo (SC)
Administered SC.
DRUGLY3462817 (IV)
Administered IV.
DRUGPlacebo (IV)
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation * Japanese participants must be first generation Japanese and have a body mass index (BMI) of 18.0 to 30.0 kilograms per square meter (kg/m²) (inclusive), and a body weight of 45 and 85 kg (inclusive) * Non-Japanese participants have a BMI of 18.0 to 32.0 kg/m² (inclusive), and a minimum body weight of 45 kg * Are males who agree to follow contraception requirements or females not of childbearing potential * Have blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
Exclusion criteria
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have cancer or a malignant disease in the past 5 years * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Are unwilling to receive study drug administration by injections or through the veins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Week 12 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817 | Predose on Day 1 through Day 85 | PK: AUC of LY3462817 |
| PK: Maximum Concentration (Cmax) of LY3462817 | Predose on Day 1 through Day 85 | PK: Cmax of LY3462817 |
Countries
United States
Outcome results
None listed