A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension
Sponsor: Neurimmune (AstraZenica)
Transthyretin amyloidosis characterised by cardiomyopathy (ATTR-CM) occurs when the protein transthyretin breaks down into individual pieces (monomers) that stick together and form amyloid, the deposits in the heart leading to heart failure. The neurimmune study (NI006) is a First-in-Human, double-blind, placebo-controlled, multicentre phase 1 study followed by an open label extension, investigating the effect of NI006 (a monoclonal antibody) on amyloid deposits in the heart.
Study Team:
Sub-I: A.Tubben
Research nurses: G. Bokhorst, G. Renkema