Healthy
Conditions
Brief summary
The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm. This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.
Interventions
DRUGLY3375880 IV
administered IV
DRUGLY3375880 SC
administered SC
DRUGPlacebo IV
administered IV
DRUGPlacebo SC
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion criteria
* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy * Are women who are of childbearing potential or who are lactating
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 | Pre-dose to 3 months after administration of study drug | 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): Area Under the Concentration Versus Time Curve (AUC) of LY3375880 | Pre-dose to 3 months after administration of study drug | PK: AUC of LY3375880 |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880 | Pre-dose to 3 months after administration of study drug | PK: Cmax of LY3375880 |
Countries
United States
Outcome results
None listed