Overview

The study is conducted in participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM), a heart disease that occurs in people with the disease ATTR amyloidosis. The purpose of this study is to see how radioactively labelled coramitug is taken up by the heart after administration through an infusion (Cohort 1), and to understand the extent to which coramitug can be displaced by radioactively labelled coramitug (Cohort 2). In this study it will also be investigated how safe coramitug is and how well it is tolerated when it is used by participants with ATTR-CM. Coramitug is potentially a new medicine for participants with ATTR-CM. Coramitug is a monoclonal antibody that potentially binds to the accumulations of the transthyretin protein and promotes its removal from the heart. It may also prevent the formation of clumps and may help with clearing existing clumps of the abnormal protein. The study will take a maximum of 85 days (for Cohort 1) or 106 days (for Cohort 2) when participating in Period A from the screening until the follow-up visit.

Eligibility

Inclusion Criteria:

• Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial
• Life expectancy of at least 3 years
• Must be 18 years or older
• Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years
• Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:
  • Patients requiring specialized cardiology care
  • Patients with inflammatory bowel diseases
  • Patients with systemic autoimmune or inflammatory diseases
  • Patients requiring long-term oral anticoagulation
  • Patients with hepatitis C
  • Patients with non-metastatic cancer

Exclusion Criteria:

• Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.
• Patients who have undergone, or are being actively considered for, liver or kidney transplantation.
• Inability to understand and give informed consent to participate.