This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.
This study is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability and PK study of NPT189 in healthy subjects. Three dose cohorts are planned each with a maximum of 8 subjects (6 active: 2 placebo) enrolled per cohort. Eligible subjects will be administered NPT189 by IV infusions at the dose specified for their cohort (i.e., 2 mg/kg, 5 mg/kg, and 12.5 mg/kg) or a matching placebo. Subjects will receive a total of 5 doses of NPT189, with doses administered at weekly intervals. Safety and tolerability will be assessed by analysis of adverse events (AEs), vital signs, electrocardiograms (ECG), laboratory and physical examinations. PK will be assessed by analysis of serum NPT189 concentrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
PRA Health Sciences
Groningen, Netherlands
Adverse event assessment in subjects receiving multiple intravenous infusions of NPT189
Summary of the frequency and percentage of adverse events
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Cmax)
Observed maximum concentration (Cmax)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Tmax)
Time of the maximum measured concentration (Tmax)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189 (AUC 0-tau)
Area under the serum concentration-time curve over a dosing interval, tau
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189. Terminal elimination half-life (t 1/2)
Terminal elimination half-life (t 1/2)
Time frame: Day 1 through DAy 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Clearance (CL)
Clearance (CL)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Volume of distribution (Vd)
Apparent volume of distribution (Vd)
Time frame: Day 1 through Day 112
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