A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection
Study Design: The study is a randomized, double-blind, parallel-group study in healthy adult male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection. A total of 168 healthy male subjects will be randomized 1:1 to receive a single subcutaneous (s.c.) injection of 60mg of either LY06006 ( LY06006 , 60 mg/1mL , Shandong Luye Pharmaceutical Co., Ltd.) or Prolia (60 mg / 1 mL , Amgen Inc.). During the entire study period, blood samples should be collected according to the Schedule of Assessments for pharmacokinetic, pharmacodynamic and immunogenicity analysis, and safety assessments should be conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
AUC 0- ∞
Area under the concentration-time curve from time zero to infinity
Time frame: 168 days
C max
Maximum observed concentration
Time frame: 168 days
s-CTX
Percent change in serum s-CTX from baseline.
Time frame: 168 days
AUEC0-t
The pharmacodynamic parameters
Time frame: 168 days
Emax
The pharmacodynamic parameters
Time frame: 168 days
TEmax
The pharmacodynamic parameters
Time frame: 168 days
Vital signs:Temperature
Safety measures
Time frame: 168 days
Vital signs:pulse
Safety measures
Time frame: 168 days
Vital signs: blood pressure
Safety measures
Time frame: 168 days
Vital signs: respiration
Safety measures
Time frame: 168 days
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Physical examination:general
Safety measures
Time frame: 168 days
Physical examination:head and neck region
Safety measures
Time frame: 168 days
Physical examination:lymph gland
Safety measures
Time frame: 168 days
Physical examination: oral cavity
Safety measures
Time frame: 168 days
Physical examination:chest
Safety measures
Time frame: 168 days
Physical examination:belly
Safety measures
Time frame: 168 days
Physical examination:Extremities and spine
Safety measures
Time frame: 168 days
Physical examination:nervous system
Safety measures
Time frame: 168 days
Laboratory tests:hematology
Safety measures
Time frame: 168 days
Laboratory tests:chemistry
Safety measures
Time frame: 168 days
Laboratory tests:urinalysis
Safety measures
Time frame: 168 days
Laboratory tests:parathyroid hormone
Safety measures
Time frame: 168 days
Laboratory tests:thyroid function
Safety measures
Time frame: 168 days
Laboratory tests:abdomen ultrasound
Safety measures
Time frame: 168 days
Laboratory tests:chest radiography
Safety measures
Time frame: 168 days
Laboratory tests:coagulation function
Safety measures
Time frame: 168 days
Electrocardiogram (12-Lead ECG)
Safety measures
Time frame: 168 days
Adverse events(AEs)
Safety measures
Time frame: 168 days
ADA
The incidence and antibody titer of ADA
Time frame: 168 days
Nab
The incidence of Nab.
Time frame: 168 days