Healthy
Conditions
Brief summary
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.
Interventions
DRUGLY3361237 - SC
LY3361237 administered SC
DRUGLY3361237 - IV
LY3361237 administered IV
DRUGPlacebo - SC
Placebo administered SC
DRUGPlacebo - IV
Placebo 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
* 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
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 Week 12 | 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 Concentration (Cmax) of LY3361237 | Predose through Week 12 | PK: Cmax of LY3361237 |
| PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237 | Predose through Week 12 | PK: AUC of LY3361237 |
Countries
United States
Outcome results
None listed