Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function. Secondary objectives: To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
90 mg Dose
Prism Research
Saint Paul, Minnesota, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Pharmacokinetics
The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F.
Time frame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Safety/Tolerability
Safety and tolerability will be evaluated by analyses of the incidence of adverse events. Vital signs, ECGs and safety laboratory parameters will be presented descriptively.
Time frame: Screening to Final Visit (Approximately 6 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.