Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI8852 · 2 trials · 1 indication
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
A serious adverse event (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. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.
Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
| Arm | Type | Description |
|---|---|---|
| Placebo + Oseltamivir 75 mg | PLACEBO_COMPARATOR | Participants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. |
| MEDI8852 750 mg + Oseltamivir 75 mg | EXPERIMENTAL | Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
| MEDI8852 3000 mg + Oseltamivir 75 mg | EXPERIMENTAL | Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
| MEDI8852 3000 mg | EXPERIMENTAL | Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1. |
| MEDI8852 | EXPERIMENTAL | MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A. |
| Placebo | PLACEBO_COMPARATOR | Solution containing no active ingredients |
| Name | Type | Description |
|---|---|---|
| Oseltamivir | DRUG | 75 mg capsules orally BID from Day 1 to Day 5. |
| MEDI8852 | DRUG | MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. |
| Placebo | DRUG | Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1. |
Inclusion Criteria: * Age 18 through 65 years at the time of screening. * Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of: * Fever of greater than or equal to (≥) 38.0 degrees Celsi...
MEDI8852 is an investigational drug being developed for influenza, a viral infection of the respiratory tract. It is being studied in adults, including those with uncomplicated influenza. The drug is currently in clinical development and has not been approved by regulatory authorities.
MEDI8852 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug for influenza.
MEDI8852 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 220 participants. The drug remains investigational and is not yet approved for any use. Further clinical studies would be needed to establish its safety and efficacy.
MEDI8852 has been studied in two completed clinical trials. NCT02350751 was a Phase 1 placebo-controlled, dose-escalation study in 94 healthy adults in the United States. NCT02603952 was a Phase 2a study in 126 adults with uncomplicated influenza in the United States and South Africa.
MEDI8852 is not FDA approved. It is an investigational drug currently in clinical development for influenza. Two Phase 1 trials have been completed, but the drug has not received marketing authorization from the FDA or any other regulatory agency.