CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.
This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®. Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
AUC0-t
Area Under Curve(AUC)0-t
Time frame: 0~126 day
Cmax
Maximum Concentration
Time frame: 0~126 day
Incidence of Adverse Event
measured by common terminology criteria for adverse events grading
Time frame: 0~126 day
Antidrug Antibody
Percentage of Subjects Positive for Antidrug Antibody
Time frame: 0~126 day
Serum type 1 C-telopeptide(CTX1)
explore the pharmacodynamic profile by detect the serum concentration of CTX1
Time frame: 0~126 day
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