Recruitment

Recruitment Status
Completed
Estimated Enrollment
Same as current

Summary

Conditions
Respiratory Syncytial Virus
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)

Participation Requirements

Age
Between 18 years and 45 years
Gender
Both males and females

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 a...

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.

Tracking Information

NCT #
NCT01562938
Collaborators
Not Provided
Investigators
Principal Investigator: Robert Feldman, MD Research Site Study Director: Hasan Jafri MedImmune LLC