This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.
This study is an open label, dose characteristic study assessing safety and pharmacokinetic and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and other relevant clinical laboratory tests. Dose administration routes will also be determined focusing on the tolerability of intravenous dose administration versus subcutaneous. The study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis. Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
Intravenous infusion for approximately 48hours followed by subcutaneous injection
GSK Investigational Site
Cambridge, United Kingdom
Blood concentrations of SAP
comparison of predicted vs observed
Time frame: 19 weeks
Plasma concentrations of GSK2315698
changes in plasma concentrations of GSK2315698 over time
Time frame: 19 weeks
safety and tolerability of GSK2315698
evaluated by adverse event (AE) reporting, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG).
Time frame: 19 weeks
Change from baseline in blood SAP levels
evaluate effect of GSK2315698 on SAP levels in the blood
Time frame: 19 weeks
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