A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg(1.7ml)and Xgeva® in healthy adults.
This is a phase I, single 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
154
Area under the plasma concentration-time curve (AUC0-t )
Time frame: 155days
Cmax
maximum concentration
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
Serum type 1 C-telopeptide(CTX1)
explore the pharmacodynamic profile by detecting the serum concentration of CTX1
Time frame: 155days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.