A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects

Study identifier:D2190C00016

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, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

100mg Mavrilimumab, 150mg mavrilimumab

Sex

All

Actual Enrollment

39

Study type

Interventional

Age

20 Years - 55 Years

Date

Study Start Date: 01 Jul 2014
Primary Completion Date: 01 Dec 2014
Study Completion Date: 01 Dec 2014

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: -
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria