Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI3902
MEDI3902- Dose 1 · 2 trials · 2 indications
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.
An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.
Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.
Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.
| 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. |
| MEDI3902 - Dose 1 | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| MEDI3902 - Dose 2 | EXPERIMENTAL | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| MEDI3902 - Dose 3 | EXPERIMENTAL | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| MEDI3902 - Dose 4 | EXPERIMENTAL | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
| 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. |
| MEDI3902 - Dose 1 | DRUG | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| MEDI3902 - Dose 2 | DRUG | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| MEDI3902 - Dose 3 | DRUG | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| MEDI3902 - Dose 4 | DRUG | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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 being developed for the prevention of Pseudomonas aeruginosa pneumonia, including nosocomial pneumonia in mechanically ventilated patients. It is an investigational agent and has not been approved for any indication. The clinical program studied its use in adults at risk of Pseudomonas aeruginosa lung infection.
MEDI3902 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the clinical studies evaluating the agent in healthy adult volunteers and in mechanically ventilated patients at risk of Pseudomonas aeruginosa pneumonia.
MEDI3902 has been studied in Phase 1 and Phase 2 clinical development. The Phase 1 study evaluated safety and pharmacokinetics in healthy adults, while a Phase 2 study assessed prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa in mechanically ventilated subjects. Both studies are completed.
MEDI3902 has been evaluated in two completed trials. NCT02255760 was a Phase 1 randomized, double-blind, placebo-controlled study of safety and pharmacokinetics in 56 healthy adults. NCT02696902 was a Phase 2 trial in 188 mechanically ventilated subjects across the United States and multiple European and Middle Eastern countries.
Yes, MEDI3902 - Dose 1 refers to the same investigational agent as MEDI3902. The dose-specific label distinguishes a particular dose level evaluated within the clinical program, but both names refer to the same AstraZeneca development compound for prevention of Pseudomonas aeruginosa pneumonia.
The Phase 2 trial, NCT02696902, was a randomized, double-blind, placebo-controlled study of 188 mechanically ventilated adults. It enrolled subjects aged 18 years and older across the United States, Austria, Belgium, Croatia, Czechia, France, Greece, Hungary, Ireland, Israel, Portugal, Spain, Turkey, and the United Kingdom.