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-1209 in Healthy Subjects. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.
32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 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
32
FuWai Hospital , Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Number of participants with adverse events
Time frame: Pre-dose to 150 days after dose administration
Assessment of PK parameter-time to maximum concentration (Tmax)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PK parameter-area under curve (AUC)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Time frame: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline
Time frame: Pre-dose to 150 days after dose administration
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