Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.
Interventions
DRUGLY3541860
Administered either IV or SC.
DRUGPlacebo
Administered either IV or 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
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are male or female not of childbearing potential * Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg) * Have veins suitable for blood sampling
Exclusion criteria
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Have active or latent TB * Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years * Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive * Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. * Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860 * Are currently participating in or completed a clinical trial within the last 30 days * Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 113 | A summary of TEAEs, 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 LY3541860 | Predose on Day 1 through Day 113 | PK: Cmax of LY3541860 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860 | Predose on Day 1 through Day 113 | PK: AUC of LY3541860 |
Countries
Japan
Outcome results
None listed