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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02144285 | A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis | PHASE1 | COMPLETED | 64 | — | — | Jun 1, 2014 | Aug 1, 2015 | Jan 22, 2019 | 3 | United States |
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event 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 all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY3113593 IV (Part A) | EXPERIMENTAL | Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels |
| Placebo IV (Part A) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered IV |
| LY3113593 SC (Part A) | EXPERIMENTAL | Single dose of LY3113593 administered subcutaneous (SC) |
| Placebo SC (Part A) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered SC |
| LY3113593 IV (Part B) | EXPERIMENTAL | Single dose of LY3113593 administered IV |
| Placebo IV (Part B) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered IV |
| Name | Type | Description |
|---|---|---|
| LY3113593 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
Inclusion Criteria: * Healthy Participants: * Healthy males or females * Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m\^2), inclusive at screening * Participants Treated with Hemodialysis: * Participants are males or females who have end-stage ren...