This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
Pharmaceutical form: water injection Route of administration: subcutaneous injection
Pharmaceutical form: water injection Route of administration: subcutaneous injection
2nd Xiangya Hospital , Chinese Academy of Medical Sciences
Changsha, Hunan, China
Safety and Tolerance: Number of subjects with adverse events
Number \& proportion of subjects with adverse events
Time frame: Dose administration to 225 days after first dose administration
Assessment of PK parameter-time to maximum concentration (Tmax)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-area under curve (AUC)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in osteocalcin from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in bone-specific alkaline phosphatase (BSAP) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum totol sclerostin
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of lumbar spine (L1-L4) from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of collum femoris from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of total hip from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Antidrug antibody
Time frame: Pre-dose to 225 days after first dose administration
Neutralizing Antibody
Time frame: Pre-dose to 225 days after first dose administration
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