Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI2338 · 1 trial · 1 indication
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Number of participants experiencing serious adverse events
Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.
Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.
Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.
Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.
| Arm | Type | Description |
|---|---|---|
| MEDI2338 10 MG | EXPERIMENTAL | MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 30 MG | EXPERIMENTAL | MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 100 MG | EXPERIMENTAL | MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 300 MG | EXPERIMENTAL | MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 1000 MG | EXPERIMENTAL | MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| Name | Type | Description |
|---|---|---|
| MEDI2338 | BIOLOGICAL | MEDI2338 single intravenous (IV) dose (lowest dose) |
| Placebo | OTHER | Placebo single IV dose |
Inclusion Criteria: * Aged ≥ 40 years at time of screening. * Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal. * Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial. * A dia...
MEDI2338 is an investigational monoclonal antibody being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is designed to address this respiratory condition, though it is not yet approved and remains in clinical development.
MEDI2338 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for Chronic Obstructive Pulmonary Disease.
MEDI2338 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, evaluating the safety of MEDI2338 in subjects with Chronic Obstructive Pulmonary Disease.
MEDI2338 has been studied in one clinical trial with the identifier NCT01322594. This Phase 1 study, titled 'A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease,' was completed and enrolled 31 participants in South Africa and the United Kingdom.
MEDI2338 is not FDA approved. It is an investigational monoclonal antibody currently in Phase 1 clinical development for Chronic Obstructive Pulmonary Disease. The drug has completed one early-stage trial, but it has not yet received regulatory approval for any use.