Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI3902- Dose 1 · 1 trial · 1 indication
An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is 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 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 - 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. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | OTHER | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
Inclusion Criteria: 1. Age 18 through 60 years at the time of screening 2. Written informed consent 3. Weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at screening 4. Healthy by medical history, physical examination, and baseline safety laboratory studi...
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.