Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI3902 · 1 trial · 1 indication
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
An SAE is 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.
An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.
| Arm | Type | Description |
|---|---|---|
| MEDI3902 500 mg | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single IV dose of placebo matched to MEDI3902. |
| MEDI3902 1500 mg | EXPERIMENTAL | Participants will receive a single IV dose of 1500 mg MEDI3902. |
| Name | Type | Description |
|---|---|---|
| MEDI3902 | DRUG | Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively. |
| Placebo | OTHER | Participants will receive a single IV dose of placebo matched to MEDI3902. |
Inclusion Criteria: Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. Exclusion Criteria: P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently r...
MEDI3902 is an investigational drug being studied for the prevention of Pseudomonas aeruginosa pneumonia, including nosocomial pneumonia in mechanically ventilated subjects. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
MEDI3902 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for preventing Pseudomonas aeruginosa infections.
MEDI3902 is in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, and it remains an investigational drug that has not been approved for any use.
MEDI3902 has been studied in two completed trials: NCT02255760, a Phase 1 study in healthy adults, and NCT02696902, a Phase 2 study in mechanically ventilated subjects. Both trials were randomized, double-blind, and placebo-controlled.
MEDI3902 is a small molecule being developed to prevent Pseudomonas aeruginosa pneumonia. Its specific molecular target has not been disclosed in the available information.