Healthy
Conditions
Brief summary
The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.
Interventions
DRUGLY3819253
Administered SC.
DRUGPlacebo
Administered SC.
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 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation including medical history and physical examination * Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected * Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (\<)35 kilograms per square meter (kg/m²) * Male participants must agree to adhere to contraception restrictions * Female participants must be of non-childbearing potential
Exclusion criteria
* Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection * Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of * Significantly altering the absorption, metabolism, or elimination of drugs * Constituting a risk while taking the investigational product, or * Interfering with the interpretation of data * Have significant allergies to humanized monoclonal antibodies (mAbs) * Have any of the following that are clinically significant: * Multiple or severe drug allergies, or * Intolerance to topical corticosteroids, or * Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis) * Have had lymphoma, leukemia, or any malignancy 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 * Have had breast cancer within the past 10 years * Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies * Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus \[HCV\] ribonucleic acid \[RNA\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 | Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose | PK: AUC\[0-∞\] of LY3819253 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo SC Participants received a single SC dose of Placebo. | 6 |
| 150 mg LY3819253 SC Participants received a single SC dose of 150 mg LY3819253. | 5 |
| 350 mg LY3819253 SC Participants received a single SC dose of 350 mg LY3819253. | 7 |
| 700 mg LY3819253 SC Participants received a single SC dose of 700 mg LY3819253. | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | 150 mg LY3819253 SC | 350 mg LY3819253 SC | 700 mg LY3819253 SC | Placebo SC | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 7 Participants | 6 Participants | 25 Participants |
| Age, Continuous | 46.0 years STANDARD_DEVIATION 16 | 45.6 years STANDARD_DEVIATION 9.2 | 41.4 years STANDARD_DEVIATION 9.2 | 47.3 years STANDARD_DEVIATION 12.8 | 44.9 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 6 Participants | 3 Participants | 6 Participants | 17 Participants |
| Region of Enrollment United States | 5 Participants | 7 Participants | 7 Participants | 6 Participants | 25 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 2 / 6 | 2 / 5 | 1 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
PK: AUC\[0-∞\] of LY3819253
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose
Population: All randomized participants who received at least one dose of LY3819253 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 150 mg LY3819253 SC | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 | NA micrograms*day per milliliter(μg*day/mL) | — |
| 350 mg LY3819253 SC | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 | 918 micrograms*day per milliliter(μg*day/mL) | Geometric Coefficient of Variation 15 |
| 700 mg LY3819253 SC | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 | 1390 micrograms*day per milliliter(μg*day/mL) | Geometric Coefficient of Variation 34 |