This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, United States
Safety and tolerability as determined by number of subjects with adverse events
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
maximum concentration (Cmax)
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(AUClast)
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(AUCinf)
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-elimination rate constant
elimination rate constant
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(t½)
terminal elimination half life (t½)
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(CL)
clearance (CL)
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(Vd)
apparent volume of distribution (Vd)
Time frame: Up to 3 months
Immunogenicity as determined by measurement of anti-PRX003 antibodies
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Time frame: Up to 3 months