Healthy
Conditions
Brief summary
The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.
Interventions
DRUGLY3461767 - SC
Administered SC.
DRUGLY3461767 - IV
Administered IV.
DRUGPlacebo - SC
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are healthy males, or females of non-child-bearing potential * Have a body mass index of 18 to 35 kilograms per square meter (kg/m²) * Have clinical laboratory tests within normal ranges as judged by investigator * Have pulse rate and blood pressure within normal ranges as judged by investigator
Exclusion criteria
* Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening * Have an abnormality in the 12-lead electrocardiogram (ECG) at screening * Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders * Regularly use known drugs of abuse * Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months * Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study * Smoke more than 10 cigarettes per day * Are current or former smokers with 30-pack-year smoking history * Have a diagnosis or history of any malignancy * Have not had appropriate cancer screening, in accordance with country specific guidance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 29 | A summary of 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): Maximum Observed Drug Concentration (Cmax) of LY3461767 | Baseline through Day 29 | PK: Cmax of LY3461767 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767 | Baseline through Day 29 | PK: AUC of LY3461767 |
Countries
Singapore, United States
Outcome results
None listed