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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01544361 | A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers | PHASE1 | COMPLETED | 125 | — | — | Jan 1, 2012 | Sep 1, 2012 | Jul 23, 2014 | 1 | United States |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 1 MG/KG | EXPERIMENTAL | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 3 MG/KG | EXPERIMENTAL | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 10 MG/KG | EXPERIMENTAL | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 20 MG/KG | EXPERIMENTAL | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 1 MG/KG | BIOLOGICAL | A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 3 MG/KG | BIOLOGICAL | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 10 MG/KG | BIOLOGICAL | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 20 MG/KG | BIOLOGICAL | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
Inclusion Criteria: * Aged 18 years up to and including 49 years at the time of first dose of investigational product * Healthy by medical history, physical examination, and laboratory studies * Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m\^2) (inclusi...