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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Coramitug will be administered intravenously
ICON - location Groningen
Groningen, Netherlands
RECRUITINGMean Standard Uptake Value Ratio (SUVRmean) in myocardium
Measured as ratio.
Time frame: Day 1-day 8
Net uptake rate constant (Ki) in myocardium
Measured as milliliter per minute per centimeter cube (mL/min/cm\^3).
Time frame: 0 to 168 hours
Change in SUVRmean in myocardium
Measured as percentage (%).
Time frame: From baseline to week 52 (day 364), or week 60 (day 420) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together
Maximum Plasma Concentration (Cmax)
microcurie (μCi)
Time frame: 0 to 168 hours
Time at which maximum plasma concentration is observed (Tmax)
Measured in hours.
Time frame: 0 to 168 hours
Area under the curve (AUC)
Measured in microcurie \*hours (μCi\*h).
Time frame: 0 to 168 hours
Terminal half-life (T1/2)
Measured in hours.
Time frame: 0 to 168 hours
Cmax
Measured in nanograms per milliliter (ng/mL).
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Tmax
Measured in hours.
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
AUC
Measured in nanograms\*hours per milliliter (ng\*h/mL).
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
T1/2
Measured in hours.
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Number of Treatment Emergent Adverse Events (TEAE)
Measured as count of events.
Time frame: From day 1 to day 8 in cohort 1 or day -1 to day 28 for cohort 2
Number of Treatment Emergent Adverse Events
Measured as count of events.
Time frame: From baseline to week 52 (day 364), or week 64 (day 448) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together
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