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

NCT02780674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-12-13

No results posted yet for this study

Summary

To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.

Conditions

  • Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Interventions

BIOLOGICAL

MEDI7734

Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.

BIOLOGICAL

Placebo

One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-26
Primary Completion
2017-10-23
Completion
2017-11-27

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780674 on ClinicalTrials.gov