Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc Clinical Trial
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
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.
;