NCT03028909

Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.

A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.

Detailed description

The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.

Conditions

• Influenza - Type A Strains

Interventions

Type	Name	Description
DRUG	Oseltamivir	Standard of care for influenza caused by Type A strains
DRUG	MEDI8852	MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
DRUG	Placebo	Salt-water solution containing no active ingredients.

Timeline

• Start date: 2017-07-24
• Primary completion: 2019-07-26
• Completion: 2019-07-26
• First posted: 2017-01-23
• Last updated: 2019-03-14

Regulatory

• FDA-regulated drug study