Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in healthy participants. The study will last about 50 days for each participant.
Detailed description
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.
Interventions
DRUGLY3471851
LY3471851 drug product is a sterile liquid for SC injection that may be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.
DRUGPlacebo
The placebo dosing solution is 0.9% sodium chloride for injection (USP).
Sponsors
Eli Lilly and Company
Nektar Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy males and females, as determined by medical history and physical examination * Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)
Exclusion criteria
* Previous or current autoimmune disease/disorder * Current active bacterial, viral, or fungal infection * Administration of an inactivated vaccine within two weeks of study drug administration or live attenuated vaccine within 90 days of dosing .
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 up to Day 50 | Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851 | Predose on Day 1 through Day 50 | PK: Cmax of LY3471851 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851 | Predose on Day 1 through Day 50 | PK: (AUC\[0-inf\]) of LY3471851 |
| Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs) | Predose on Day 1 through Day 50 | PD: Mean change from baseline in Tregs |
| PD: Change from Baseline in Treg Activation Markers | Predose on Day 1 through Day 50 | PD: Treg activation markers include: Cytokine levels, conventional CD4+ and CD8+ Tcells, and natural killer (NK) cells |
Countries
United States
Outcome results
None listed