Conditions: Influenza
Keywords: Influenza Influenza A Flu Flu A
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 126
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.

Detailed description:
The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.

Interventions: intervention 1: Oseltamivir intervention 2: MEDI8852 intervention 3: Placebo
Intervention descriptions: intervention 1: 75 mg capsules orally BID from Day 1 to Day 5. intervention 2: MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. intervention 3: Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.

Protocol document: