Fig 1.
Study design and volunteers disposition.
aOne volunteer withdrew consent before administration of study treatment. bVolunteers from placebo group were not included for PK assessment. cOne volunteer who received denosumab 60 mg withdrew from study (investigator discretion; study day 147). PK, pharmacokinetic; PD, pharmacodynamic; Wk, week.
Table 1.
Demographic and baseline characteristics (safety population).
Fig 2.
Mean serum concentration-time plot of denosumab following single subcutaneous administration at doses of 60 mg and 120 mg.
Error bar represents standard deviation.
Table 2.
Summary of pharmacokinetic parameters of denosumab after single-dose subcutaneous administration (PK population).
Fig 3.
Change from baseline in median serum CTX1.
Error bar represents range. CTX1, C-terminal cross-linking telopeptide of type I collagen.
Table 3.
Summary of pharmacodynamic parameters of serum CTX1 (PD population).
Table 4.
Treatment-emergent adverse events occurring in ≥2 volunteers in any group (safety population).
Table 5.
Denosumab pharmacokinetic and pharmacodynamic comparison for Chinese and non-Chinese population.