Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01477567 | A First-in-Human Study of LY3009385 in Healthy Participants | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2011 | Mar 1, 2012 | Oct 6, 2014 | 1 | Singapore |
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| 0.3 mg LY3009385 | EXPERIMENTAL | LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 1 mg LY3009385 | EXPERIMENTAL | LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 3 mg LY3009385 | EXPERIMENTAL | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 9 mg LY3009385 | EXPERIMENTAL | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 22 mg LY3009385 | EXPERIMENTAL | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 54 mg LY3009385 | EXPERIMENTAL | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 |
| Name | Type | Description |
|---|---|---|
| LY3009385 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Are a healthy male or a female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) at screening * Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study * Have vei...