Study to Assess How Coramitug Acts on Heart Amyloid Deposits Using PETCT Imaging in People with Transthyretin Amyloid Cardiomyopathy

What this Trial Is About

Researchers are studying Transthyretin Amyloid Cardiomyopathy ATTR-CM, a heart disease caused by abnormal protein deposits in the heart. This study aims to understand how a drug called coramitug, a monoclonal antibody, is taken up by the heart and how it may help remove these harmful protein clumps. The trial also evaluates the safety and tolerance of coramitug in participants with ATTR-CM. Participants are divided into two groups. Cohort 1 will receive an infusion of radioactively labelled coramitug to measure its uptake by the heart. Cohort 2 will assess how unlabelled coramitug affects the distribution of the labelled drug and whether it can displace it. Coramitug is given intravenously, and the study includes a screening period, treatment, and follow-up lasting up to 85 days for Cohort 1 or 106 days for Cohort 2. During the study, participants will undergo PETCT imaging and other evaluations to measure how much coramitug binds to heart tissue and its effects over time. Researchers will monitor heart uptake values, plasma concentrations of the drug, and safety through adverse event tracking. The studys primary measurements occur between the first day and up to one year after treatment, with follow-up visits to assess long-term effects and safety.

A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis.