Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2053 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH2053 on Day 1. |
|
| Placebo SAD group | Placebo Comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2053 | Drug | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 | The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0 | Pre-dose and multiple timepoints no less than 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| The serum LDL-C level after dosing SYH2053 | measure the LDL-C level in blood by lab examination and evaluate the effect of SYH2053 on LDL-C Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum PCSK9 level after dosing SYH2053 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10 Chedaogou Rd.,Haidian District, Beijing, China | Beijing | Beijing Municipality | China |
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
subcutaneous injection |
|
measure the PCSK9 level in blood by lab examination and evaluate the effect of SYH2053 on PCSK9 Level
| Pre-dose and multiple timepoints no less than 57 days |
| PK parameters (Cmax) | maximum peak observed plasma SYH2053 concentration in treated subjects | Pre-dose and multiple timepoints up to 4 days |
| PK parameters (Tmax) | time to reach maximum peak plasma SYH2053 concentration in treated subjects | Pre-dose and multiple timepoints up to 4 days |
| PK parameters (AUC) | area under the plasma concentration-time curve in SYH2053 treated subjects | Pre-dose and multiple timepoints up to 4 days |
| PK parameters (T1/2) | the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in SYH2053 treated subjects | Pre-dose and multiple timepoints up to 4 days |
| Immunogenicity of SYH2053 | Rate of formation of anti-drug antibodies to SYH2053 | Pre-dose and multiple timepoints up to 57 days |
| The serum TC level after dosing SYH2053 | measure the TC level in blood by lab examination and evaluate the effect of SYH2053 on TC Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum TG level after dosing SYH2053 | measure the TG level in blood by lab examination and evaluate the effect of SYH2053 on TG Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum HDL-C level after dosing SYH2053 | measure the HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on HDL-C Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum Lp(a) level after dosing SYH2053 | measure the Lp(a) level in blood by lab examination and evaluate the effect of SYH2053 on Lp(a) Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum VLDL-C level after dosing SYH2053 | measure the VLDL-C level in blood by lab examination and evaluate the effect of SYH2053 on VLDL-C Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum non-HDL-C level after dosing SYH2053 | measure the non-HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on non-HDL-C Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum ApoA1 level after dosing SYH2053 | measure the ApoA1 level in blood by lab examination and evaluate the effect of SYH2053 on ApoA1 Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum ApoB level after dosing SYH2053 | measure the ApoB level in blood by lab examination and evaluate the effect of SYH2053 on ApoB Level | Pre-dose and multiple timepoints no less than 57 days |
| The serum hsCRP level after dosing SYH2053 | measure the hsCRP level in blood by lab examination and evaluate the effect of SYH2053 on hsCRP Level | Pre-dose and multiple timepoints no less than 57 days |