The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Group A:SHR6508 low dose
Group B:SHR6508 medium dose
Group C:SHR6508 high dose
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Tmax, Time of maximum observed concentration.
Time frame: 0 hour to 43 hours after first dose administration
Cmax, Maximum observed concentration.
Time frame: 0 hour to 43 hours after first dose administration
AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.
Time frame: 0 hour to 43 hours after first dose administration
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
Time frame: 0 hour to 43 hours after first dose administration
t1/2z, Terminal elimination half-life
Time frame: 0 hour to 43 hours after first dose administration
CLz, Total Body Clearance
Time frame: 0 hour to 43 hours after first dose administration
Vz, Volume of distribution based on the terminal phase
Time frame: 0 hour to 43 hours after first dose administration
MRT0-t, Mean residence time from time zero to the last measurable concentration.
Time frame: 0 hour to 43 hours after first dose administration
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
Time frame: 0 hour to 43 hours after first dose administration
Cmax,ss : Maximum observed concentration at steady-state.
Time frame: Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration at steady-state
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Group D:SHR6508 high dose(single dose)
Time frame: Day1-Day29(if reach steady-state)
Cav : Average concentration
Time frame: Day1-Day29(if reach steady-state)
AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.
Time frame: Day1-Day29(if reach steady-state)
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
Time frame: Day1-Day29(if reach steady-state)
Tmax,ss, Time of maximum observed concentration at steady-state.
Time frame: Day1-Day29(if reach steady-state)
t1/2z,ss, Terminal elimination half-life at steady-state
Time frame: Day1-Day29(if reach steady-state)
CLss, Total Body Clearance at steady-state.
Time frame: Day1-Day29(if reach steady-state)
Vss, Volume of distribution based on the terminal phase at steady-state.
Time frame: Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
Time frame: Day1-Day29(if reach steady-state)
DF: Degree of Fluctuation
Time frame: Day1-Day29(if reach steady-state)
Accumulation Ratio
Time frame: Day1-Day29(if reach steady-state)
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
iPTH, FGF23 and BSAP were tested at a central laboratory.
Time frame: 0 hour to 43 hours after first dose administration
Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP
iPTH, FGF23 and BSAP were tested at a central laboratory.
Time frame: Day1 to Day29
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
iPTH was tested at a central laboratory.
Time frame: Day1 to Day29
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory
Time frame: Day1 to Day29
Participants With Treatment-Emergent Adverse Events (TEAEs)
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: Day1 to End of Study, End of Study is about Day55