NCT02603952

A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

A Phase 2a, Randomized, Partial Double-blind, Single Dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults With Acute, Uncomplicated Influenza

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Oseltamivir	75 mg capsules orally BID from Day 1 to Day 5.
DRUG	MEDI8852	MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.
DRUG	Placebo	Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.

Timeline

• Start date: 2015-12-07
• Primary completion: 2016-12-09
• Completion: 2016-12-09
• First posted: 2015-11-13
• Last updated: 2018-06-08
• Results posted: 2018-06-08

Locations

31 sites across 2 countries: United States, South Africa