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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01322594 | A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease | PHASE1 | COMPLETED | 31 | — | — | Mar 1, 2011 | Dec 1, 2011 | Oct 23, 2013 | 4 | South Africa, United Kingdom |
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...