This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1222 in healthy subjects including assessment of immunogenicity.
50 adult healthy subjects with 5 dose groups will be enrolled in the study, including six subjects in the lowest dose group, four of whom received the SHR-1209 and two of whom received the placebo. The other three groups have 11 subjects in each group, 9 administered SHR-1222 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
2nd Xiangya Hospital of Central South University
Changsha, China
Number & proportion of subjects with adverse events [Time Frame: dose administration to 85 days after dose administration] Safety and Tolerance: Number & proportion of subjects with adverse events
Time frame: Dose administration to 85 days after dose administration
Assessment of PK parameter-time to maximum concentration (Tmax)
Time frame: Pre-dose to 85 days after dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Time frame: Pre-dose to 85 days after dose administration
Assessment of PK parameter-area under curve (AUC)
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in osteocalcin from baseline
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in bone-specific alkaline phosphatase (BSAP) from baseline
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in areal bone mineral density of lumbar spine (L1-L4 mean T value) from baseline
by dualenergy X-ray absorptiometry
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Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in areal bone mineral density of collum femoris (T value) from baseline
by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in volumetric bone mineral density of lumbar spine (L1-L4 mean T value) from baseline
by quantitative computed tomography
Time frame: Pre-dose to 85 days after dose administration
Assessment of PD parameter-change in volumetric bone mineral density of collum femoris (T value) from baseline
by quantitative computed tomography
Time frame: Pre-dose to 85 days after dose administration
Antidrug antibody concentration
Time frame: Pre-dose to 85 days after dose administration