The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Ascending doses administered by intravenous (IV) infusion
Calculated volume to match active comparator
Clinical Site
London, United Kingdom
The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation
Time frame: Up to 28 days
Pharmacodynamics (PD) of ALN-TTR02 (serum concentrations of Transthyretin, Vitamin A, and Retinol Binding Protein)
Time frame: Up to 90 days
Observed maximum concentration (Cmax) of ALN-TTR02
Time frame: Up to 90 days
Time of observed maximum concentration (tmax) of ALN-TTR02
Time frame: Up to 90 days
Area under the plasma concentration versus time curve (AUC) of ALN-TTR02
Time frame: Up to 90 days
Terminal elimination half-life (t1/2) of ALN-TTR02
Time frame: Up to 90 days
Systemic clearance (CL) of ALN-TTR02
Time frame: Up to 90 days
Volume of distribution (V) of ALN-TTR02
Time frame: Up to 90 days
Renal clearance (CLR) of ALN-TTR02
Time frame: Up to 90 days
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