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| ID | Type | Description | Link |
|---|---|---|---|
| I7P-MC-DSAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.
Protocol amended in January, 2016 to include first generation Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3041658 (IV) | Experimental | Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts. |
|
| LY3041658 (SC) | Experimental | Single dose of LY3041658 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3041658 (SC) | Drug | Administered SC |
| |
| LY3041658 (IV) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants with One or More Drug-Related Adverse Events | Baseline to study completion (Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658 | Predose through Day 85, at specified timepoints | |
| Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast) | Predose through Day 85, at specified timepoints |
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Inclusion Criteria:
All:
First-generation Japanese:
Exclusion Criteria:
- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 90216 | United States | ||
| PAREXEL-Phase 1 Baltimore Harbor Hospital Center |
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| Drug |
Administered as slow IV infusion |
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| Placebo | Drug | Administered as slow IV infusion |
|
| Baltimore |
| Maryland |
| 21225 |
| United States |