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| ID | Type | Description | Link |
|---|---|---|---|
| I8C-MC-GSFA | Other Identifier | Eli Lilly and Company |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (SC) | Placebo Comparator | Single subcutaneous (SC) dose of placebo |
|
| LY3200327 (SC) | Experimental | Single escalating subcutaneous (SC) dose of LY3200327 |
|
| LY3200327 (IV) | Experimental | Single intravenous (IV) dose of LY3200327 |
|
| Placebo (IV) | Placebo Comparator | Single intravenous (IV) dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (SC) | Drug | Administered SC |
| |
| LY3200327 (SC) |
| 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 | Baseline to study completion (approximately 12 weeks) |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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 International/ California Clinical Trials | Glendale | California | 91206 | United States |
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| Drug |
Administered SC |
|
| LY3200327 (IV) | Drug | Administered IV |
|
| Placebo (IV) | Drug | Administered IV |
|