A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects

Study identifier:CD-ID-MEDI4893-1133

ClinicalTrials.gov identifier:N/A

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 MEDI4893, an Extended Half-Life Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin, in Healthy Adult Subjects

Medical condition

Staphylococcus aureus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Placebo, MEDI4893

Sex

All

Actual Enrollment

85

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jan 2013
Primary Completion Date: 01 May 2014
Study Completion Date: 01 May 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Jul 2014 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria