NCT01475305

Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)

A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged With Respiratory Syncytial Virus (RSV)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.

Detailed description

This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Participants will be inoculated with RSV-A. Participants will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
DRUG	MEDI-557	Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.

Timeline

• Start date: 2011-10-20
• Primary completion: 2011-12-03
• Completion: 2012-12-13
• First posted: 2011-11-21
• Last updated: 2017-07-21
• Results posted: 2017-07-21

Locations

1 site across 1 country: United Kingdom