A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

Study identifier:D6080C00001

ClinicalTrials.gov identifier:NCT02780674

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Blinded, Single-Dose, Dose escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

Medical condition

Dermatomyositis, polymyositis, Sjogren's, SLE, SSc

Phase

Phase 1

Healthy volunteers

No

Study drug

MEDI7734 1 mg, Placebo, MEDI7734 5 mg, MEDI7734 15 mg, MEDI7734 50 mg, MEDI7734 150 mg

Sex

All

Actual Enrollment

36

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 26 Aug 2016
Primary Completion Date: 23 Oct 2017
Study Completion Date: 27 Nov 2017

Study design

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

Verification:

Verified 01 Dec 2018 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria