This is a Phase 1, double-blind, placebo-controlled, single ascending dose study in participants with elevated uric acid levels. This study will be conducted in approximately 64 adult male and female participants in the dose escalation phase.
Participants will be assigned to 1 of 8 sequential dosing cohorts, each composed of 8 participants (6 active + 2 placebo) who will receive a single dose of PRX-115 or placebo by intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
New Zealand Clinical Research
Grafton, Auckland, New Zealand
New Zealand Clinical Research
Christchurch, Christchurch, New Zealand
Number of participants with adverse events receiving PRX-115 compared to placebo
To assess the safety and tolerability of a single infusion of PRX-115 as assessed by frequency of drug related adverse events, graded by severity.
Time frame: Day 0 - Day 85
Number of participants with abnormal clinically significant clinical laboratory results
Clinical laboratory tests include hematology, coagulation and biochemistry
Time frame: Day 0 - Day 85
Number of participants with abnormal clinical vital signs
Vital signs include pulse rate, blood pressure, respiratory rate and tympanic temperature
Time frame: Day 0 - Day 85
Number of participants with abnormal clinically significant results from physical examination
Time frame: Day 0 - Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: Day 0 - Day 85
PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
The Cmax PK parameter calculated based on the observed plasma drug concentration versus time curve
Time frame: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
The PK parameter calculated will be Area under the plasma drug concentration-time curve of the last measurable drug concentration (AUC0-t).
Time frame: Day 1 - Day 85
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PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
The PK parameter calculated will be Time to maximum observed plasma drug concentration (T max).
Time frame: Day 1 - Day 85
PK of PRX-115: total body clearance (CL)
The PK parameter calculated will be total body clearance (CL).
Time frame: Day 1 - Day 85
PK of PRX-115: volume of distribution during the terminal phase (Vd)
The PK parameter calculated will be volume of distribution during the terminal phase (Vd).
Time frame: Day 1 - Day 85
PK of PRX-115: Terminal elimination half-life (T ½)
The PK parameter of Terminal elimination half-life (T ½) is calculated based on the plasma drug concentration-time curve
Time frame: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
The PK parameters calculated will be Area under the plasma drug concentration-time curve from time 0 to infinity (AUC0-inf).
Time frame: Day 1 - Day 85
Pharmacodynamics of PRX-115: blood uric acid levels
Pharmacodynamics of PRX-115 by measurement of blood uric acid levels over 85 days
Time frame: Day 0 - Day 85
Immunogenicity of PRX-115: measurement of anti-drug antibody levels
Time frame: Day 1 - Day 85