Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI7814,KG · 1 trial · 1 indication
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...
MEDI7814 is an investigational monoclonal antibody developed by AstraZeneca PLC (ticker AZN). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications for MEDI7814 have not been disclosed. It is not approved for any use and remains in clinical development.
MEDI7814 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 study of MEDI7814. No partnership or licensing details for this asset have been disclosed.
MEDI7814 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
MEDI7814 has been evaluated in one completed Phase 1 trial, NCT01544361, titled "A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers." The trial enrolled 125 healthy adult participants in the United States and was randomized, double-blind, and placebo-controlled.