A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® 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 and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. Meanwhile,observing the pharmacodynamic similarities of QL1206 or Prolia® preliminarily. Subjects would receive a single 60mg(1ml) of QL1206 or through subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGArea under the plasma concentration-time curve (AUC0-t )
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.
Time frame: 134 day
maximum plasma concentration(Cmax)
the maximum plasma concentration of QL1206/Prolia from 0 o'clock to the last measurable concentration acquisition time t.
Time frame: 134 day
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: 134 day
serum CTX1
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis. the secondary outcome measures the percent change in serum CTX1 throughout the study from baseline to 134 day
Time frame: 134 day
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