NCT00578682

A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody With an Extended Half-Life Against Respiratory Syncytial Virus (RSV), in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of a single IV dose of MEDI-557.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-557	Single IV dose of 3 mg/kg
BIOLOGICAL	MEDI-557	Single IV dose of 15 mg/kg
BIOLOGICAL	MEDI-557	Single IV dose of 30 mg/kg
BIOLOGICAL	MEDI-557	Single IV dose of 0.3 mg/kg

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2007-12-21
• Last updated: 2011-11-23

Locations

1 site across 1 country: United States