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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02603952 | A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza | PHASE1 | COMPLETED | 126 | — | — | Dec 7, 2015 | Dec 9, 2016 | Jun 8, 2018 | 31 | United States, South Africa |
| NCT02350751 | Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults | PHASE1 | COMPLETED | 94 | — | — | Jan 1, 2015 | Jun 1, 2015 | Jul 13, 2015 | 1 | United States |
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...