Amyloidosis Clinical Trial
Official title:
A Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic Amyloidosis
The study will be conducted in two parts. The first (Part A) will be an open label single
dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5
milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose
levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be
administered at variable doses until the concentration of the serum amyloid P component
monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions
about these next dose levels will be made following safety review of the prior subjects'
data; dose levels may be changed (increased and lowered) and dose levels may be repeated
depending on the observed safety such that Part A extension study may be performed. In
addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and
circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to
the highest well tolerated dose or the highest allowable dose. Subjects will be closely
monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including
organ volume, Elastography and Liver Biopsy if required.
Part B will be a randomized partially blinded part with the principal objective of assessing
the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of
approximately 5 dose groups from Part A. The precise selection of numbers of subjects and
dose levels will be informed by the results from Part A.
n/a
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