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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03418493 | A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis | PHASE1 | COMPLETED | 63 | — | — | Jan 30, 2018 | Jul 29, 2019 | Sep 21, 2023 | 2 | United States |
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
| Arm | Type | Description |
|---|---|---|
| LY3316531 (Part A) | EXPERIMENTAL | Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC). |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo matching LY3316531 administered IV. |
| LY3316531 (Part B) | EXPERIMENTAL | Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks). |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo matching LY3316531 administered IV. |
| LY3316531 (Part C) | EXPERIMENTAL | Participants with psoriasis received single doses of 300 mg LY3316531 administered IV. |
| Name | Type | Description |
|---|---|---|
| LY3316531 - IV | DRUG | Administered IV. |
| LY3316531 - SC | DRUG | Administered SC. |
| Placebo - IV | DRUG | Administered IV. |
Inclusion Criteria: * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination * Females must be of non-childbearing potential * Are between 18 and 64 years of age, inclusive, at screening * Have a body mass index of 18.0 to 32....