A 6-Part Study In Healthy Volunteers To Evaluate Safety, Tolerability and Uptake Of MEDI7219 in the Body when given as Single and Multiple Doses

Study identifier:D8170C00001

ClinicalTrials.gov identifier:NCT03362593

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI7219, Placebo, Formulation without Active Drug

Sex

All

Actual Enrollment

186

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 04 Dec 2017
Primary Completion Date: 11 May 2020
Study Completion Date: 11 May 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2021 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria