NCT01562938

MEDI-557 Adult Dosing

A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.

Detailed description

A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	MEDI-557	MEDI-557 low-dose
DRUG	MEDI-557	MEDI-557 high-dose

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-03-26
• Last updated: 2013-10-07

Locations

1 site across 1 country: United States