Phase 1 Randomized Double-blind Placebo controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults

Study identifier:D5470C00002

ClinicalTrials.gov identifier:NCT02255760

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults

Medical condition

MEDI3902 for prevention of P. aeruginosa pneumonia

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI3902 – Dose 1, MEDI3902 – Dose 2, MEDI3902 – Dose 3, MEDI3902 – Dose 4

Sex

All

Actual Enrollment

56

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 04 Sept 2014
Primary Completion Date: 20 Apr 2015
Study Completion Date: 20 Apr 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2017 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria