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,KG is an investigational monoclonal antibody being studied in healthy subjects. It is currently in Phase 1 clinical development, meaning it has not been approved for any medical use. The drug is being evaluated for safety in adult volunteers.
MEDI7814,KG is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety of this investigational monoclonal antibody.
MEDI7814,KG is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is designed to evaluate the safety of the drug in healthy adult volunteers.
MEDI7814,KG has one completed clinical trial registered under NCT01544361, titled "A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers." This trial was conducted in the United States and enrolled 125 healthy adult participants.
Yes, MEDI7814,KG is the same drug as MEDI7814. The clinical trial NCT01544361 refers to the drug as MEDI7814, and the KG suffix is an alternative designation. Both names refer to the same investigational monoclonal antibody developed by AstraZeneca.