This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows: 1. SHR-1209 dose 1 /placebo frequence 1 2. SHR-1209 dose 2 /placebo frequence 2 3. SHR-1209 dose 3 /placebo frequence 3 4. SHR-1209 dose 4 /placebo frequence 1 5. SHR-1209 dose 5 /placebo frequence 2 6. SHR-1209 dose 6 /placebo frequence 3
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Sun Yat-Sen Memorial Hospital ,The Second Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C.
Time frame: Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6
Primary safety end point:Number of subjects with adverse events.
Time frame: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5
Absolute change from baseline to end of the dosing interval in LDL-C.
Time frame: Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6
Percent change from baseline to day 85 in LDL-C.
Time frame: Baseline to day 85 for all 6 groups
Absolute change from baseline to day 85 in LDL-C.
Time frame: Baseline to day 85 for all 6 groups
Percent change in PCSK9.
Time frame: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5
Absolute change in PCSK9.
Time frame: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5
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