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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04495478 | A Study of Ramucirumab (LY3009806) in Healthy Participants | PHASE1 | COMPLETED | 50 | — | — | Jul 30, 2020 | May 9, 2021 | Feb 14, 2023 | 1 | United States |
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, 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. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of participants showing ISRs when the drug was administered subcutaneously were reported.
PK: AUC\[0-∞\] of Ramucirumab.
PK: Cmax of Ramucirumab
| Arm | Type | Description |
|---|---|---|
| Placebo - Intravenous (IV) | EXPERIMENTAL | Participants received single dose of placebo administered IV. |
| 350 mg Ramucirumab IV | PLACEBO_COMPARATOR | Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion. |
| Placebo - Subcutaneous (SC) | EXPERIMENTAL | Participants received single dose of placebo administered SC. |
| 350 mg Ramucirumab SC (1x2 mL) | PLACEBO_COMPARATOR | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
| 350 mg Ramucirumab SC (2x2 mL) | EXPERIMENTAL | Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
| 350 mg Ramucirumab SC (2x1 mL) | EXPERIMENTAL | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
| 700 mg Ramucirumab SC (2x2 mL) | EXPERIMENTAL | Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
| Name | Type | Description |
|---|---|---|
| Ramucirumab - IV | DRUG | Administered IV. |
| Placebo - IV | DRUG | Administered IV. |
| Ramucirumab - SC | DRUG | Administered SC. |
| Placebo - SC | DRUG | Administered SC. |
Inclusion Criteria: * Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive * Have nor...