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In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1209 single-site subcutaneous injection | Drug | SHR-1209 single-site subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209. | After injection in day 1 and day 57. | |
| Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209. | After injections in day 1 and day 57. | |
| Area under the curve (AUC0-56). | After injection in day 1 up to day 56. | |
| Peak time (Tmax) of SHR-1209. | After injection in day 1 up to day 56. | |
| Peak concentration (Cmax) of SHR-1209. | After injection in day 1 up to day 56. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' preferred method of SHR-1209 administration between the tested injection regimens. | Day 68. | |
| Incidence and severity of adverse events (AEs). | From Day 1 to Day 169. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | 230000 | China |
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| SHR-1209 multiple-site subcutaneous injections | Drug | SHR-1209 multiple-site subcutaneous injections. |
|
| Incidence and severity of serious adverse events (SAEs). |
| From Day 1 to Day 169. |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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