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| ID | Type | Description | Link |
|---|---|---|---|
| J1P-MC-KFAA | Other Identifier | Eli Lilly and Company | |
| 16-358-01 | Other Identifier | Nektar Therapeutics |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3471851 | Experimental | Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851. |
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| Placebo | Placebo Comparator | Healthy participants in each cohort will receive the placebo comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3471851 | Drug | 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. |
| Measure | Description | 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 | Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Predose on Day 1 through Day 50 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Lenexa | Kansas | 66219 | United States |
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| Placebo | Drug | The placebo dosing solution is 0.9% sodium chloride for injection (USP). |
|
PK: (AUC[0-inf]) of LY3471851
| Predose on Day 1 through Day 50 |
| Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs) | PD: Mean change from baseline in Tregs | Predose on Day 1 through Day 50 |
| PD: Change from Baseline in Treg Activation Markers | PD: Treg activation markers include: Cytokine levels, conventional CD4+ and CD8+ Tcells, and natural killer (NK) cells | Predose on Day 1 through Day 50 |