A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
174
Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
Subcutaneously injection of Prolia® (60mg/1mL) once on the first day
Huazhong University of Science and Technoogy
Wuhan, Hubei, China
RECRUITINGArea under the plasma concentration-infinity curve (AUC0-∞ )
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.
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
ADA
percentage of subjects positive for antidrug antibody
Time frame: 155days
Nab
percentage of subjects positive for Nab
Time frame: 155days
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