NCT02350751

Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults

A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.

Detailed description

This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	MEDI8852
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-01-30
• Last updated: 2015-07-13

Locations

1 site across 1 country: United States