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. Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Danbury, Connecticut, United States
Research Site
DeBary, Florida, United States
Incidence of Treatment-Emergent Adverse Event
The safety and tolerability of MEDI7734 as measured by the incidence of any adverse events that occur on or after the day of administration of investigational product through the end of follow-up. Laboratory measurements, vital sign measurements, and electrocardiogram (ECG) parameters will also be evaluated as part of safety.
Time frame: Day 85
Anti-drug antibodies
Presence of anti-drug antibodies (ADA)
Time frame: Day 85
Pharmacokinetics Cmax
Maximum concentration of drug achieved
Time frame: Day 85
Pharmacokinetics Tmax
Time at which maximum concentration of drug is achieved
Time frame: Day 85
Pharmacokinetic
Half Life
Time frame: Day 85
Pharmacokinetic
AUC
Time frame: Day 85
Pharmacodynamics
Blood levels of plasmacytoid cells.
Time frame: Day 85
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Research Site
Jacksonville, Florida, United States
Research Site
Miami Springs, Florida, United States
Research Site
Duncansville, Pennsylvania, United States