A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults
This is a phase I, dual-center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile, observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
Haikou People's Hospital
Haikou, Hainan, China
RECRUITINGAUC0-∞
The area under the curve from time 0 extrapolated to infinite time
Time frame: 155days
Cmax
Maximum concentration
Time frame: 155days
AUC0-t
Area under the plasma concentration-time curve
Time frame: 155days
Tmax
Time to reach Cmax
Time frame: 155days
t1/2z
Terminal half-life
Time frame: 155days
Vz/F
Apparent volume of distribution
Time frame: 155days
CLz/F
Apparent clearance
Time frame: 155days
Serum type 1 C-telopeptide(CTX1)
explore the pharmacodynamic profile by detecting the serum concentration of CTX1
Time frame: 155days
Imin
The minimum observed concentration
Time frame: 155days
TEmax
Time to reach the maximum inhibition rate
Time frame: 155days
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Emax
Maximum observed inhibition rate
Time frame: 155days
AUEC0-t
Area under the plasma effect-time curve from time zero to last time of quantifiable concentrationthe
Time frame: 155days
Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Time frame: 155days
Antidrug antibody(ADA):
percentage of subjects positive for antidrug antibody
Time frame: 155days
Neutralizing antibody(Nab)
percentage of subjects positive for Nab
Time frame: 155days