A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Study identifier:D5290C00001

ClinicalTrials.gov identifier:NCT02114268

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Medical condition

Respiratory Syncytial Virus Infections

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI8897 Intravenous, Placebo, MEDI8897 Intravenous, MEDI8897 Intravenous, MEDI8897 Intramuscular, MEDI8897 Intramuscular

Sex

All

Actual enrollment

342

Study type

Interventional

Age

18 Years - 49 Years

Date

Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Jun 2015
Study Completion Date: 01 Jun 2015

Study design

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

Verification:

Verified 01 Oct 2016 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria