Healthy
Conditions
Brief summary
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body. The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
Interventions
DRUGPlacebo (SC)
Administered SC
DRUGLY3200327 (SC)
Administered SC
DRUGLY3200327 (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
* At the time of initial screening, in general good health * First-generation healthy Japanese (age 20 to 65 years) will be included
Exclusion criteria
* Pregnancy or breastfeeding during the study * Chronic infection * Treatment with prohibited medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to study completion (approximately 12 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327 | Pre-dose up to 84 days post dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327 | Pre-dose up to 84 days post dose |
Countries
United States
Outcome results
None listed