Philippine Biological Technology (Jilin) ​​Co Ltd

This study aimed to study the pharmacokinetic characteristics of alendronate sodium tablets (70 mg) developed and produced by Feiyang Biotechnology (Jilin) Co., Ltd. after a single fasting oral administration; using alendronate sodium tablets (Fosamax®, 70 mg) certified by N.V.Organon as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.

Main study objective: In postmenopausal women with osteoporosis, evaluate the change rate of lumbar spine (L1-L4) bone mineral density (BMD) from baseline to month 12 in subjects treated with KN012 and Prolia®. Secondary study objectives: In postmenopausal women with osteoporosis, to evaluate the change rate of lumbar spine (L1-L4) BMD from baseline to month 6 in the two treatment groups; to evaluate the change rate of hip, femoral neck, trochanter, and forearm BMD from baseline to month 6 and month 12 in the two treatment groups; to evaluate the change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) and serum type I procollagen N-terminal propeptide (s-PINP) from baseline to month 1, 3, 6, 9, and 12; to evaluate the effective rate of bone mineral density change and the incidence of fractures; to evaluate the safety of the two treatment groups, including immunogenicity; to conduct population pharmacokinetic (PopPK) analysis to evaluate the PK similarity between KN012 and Prolia®.

The main purpose of the study is to observe the pharmacokinetic characteristics of recombinant fully human anti-RANKL monoclonal antibody injection, and use Denosumab (trade name: Prolia) as the reference preparation to compare the main pharmacokinetic parameters of the two preparations and evaluate the pharmacokinetic similarity of the two preparations. The secondary purpose of the study is to compare the safety and clinical immunogenicity of a single dose of 60 mg of the test preparation, recombinant fully human anti-RANKL monoclonal antibody injection, and the reference preparation Prolia in healthy subjects.