Study identifier:D6080C00001
ClinicalTrials.gov identifier:NCT02780674
EudraCT identifier:N/A
CTIS identifier:N/A
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
Dermatomyositis, polymyositis, Sjogren's, SLE, SSc
Phase 1
No
MEDI7734 1 mg, Placebo, MEDI7734 5 mg, MEDI7734 15 mg, MEDI7734 50 mg, MEDI7734 150 mg
All
36
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2018 by MedImmune, LLC
MedImmune, LLC
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To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo. The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren’s syndrome, systemic lupus erythematosus, or systemic sclerosis. After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.
Location
Location
Duncansville, PA, United States, 16635
Location
Anniston, AL, United States, 36207
Location
Debary, FL, United States, 32713
Location
Danbury, CT, United States, 06810
Location
Birmingham, AL, United States, 35294
Location
Miami Springs, FL, United States, 33166
Location
Jacksonville, FL, United States, 32216
Arms | Assigned Interventions |
---|---|
Experimental: MEDI7734 1 mg Participants received a single dose of 1 milligram (mg) MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 1 mg Participants received a single dose of 1 milligram (mg) MEDI7734 subcutaneously on Day 1. |
Placebo Comparator: Placebo Participants received a single dose of placebo matching with MEDI7734 subcutaneously on Day 1. | Drug: Placebo Participants received a single dose of placebo matching with MEDI7734 subcutaneously on Day 1. |
Experimental: MEDI7734 5 mg Participants received a single dose of 5 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 5 mg Participants received a single dose of 5 mg MEDI7734 subcutaneously on Day 1. |
Experimental: MEDI7734 15 mg Participants received a single dose of 15 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 15 mg Participants received a single dose of 15 mg MEDI7734 subcutaneously on Day 1. |
Experimental: MEDI7734 50 mg Participants received a single dose of 50 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 50 mg Participants received a single dose of 50 mg MEDI7734 subcutaneously on Day 1. |
Experimental: MEDI7734 150 mg Participants received a single dose of 150 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 150 mg Participants received a single dose of 150 mg MEDI7734 subcutaneously on Day 1. |
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