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This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRSD216 injection (Part 1) | Experimental | SRSD216 administered SC. in subjects of Part 1 |
|
| SRSD216 injection (Part 2) | Experimental | SRSD216 administered SC. in subjects of Part 2 |
|
| 0.9% Sodium Chloride (Part 1) | Experimental | Placbo administered SC. in subjects of Part 1 |
|
| 0.9% Sodium Chloride (Part 2) | Placebo Comparator | Placbo administered SC. in subjects of Part 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRSD216 injection | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | A summary of TEAE to evaluate the safety and tolerability of SRSD216 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | +86 21 61207756 | medical@siriusrna.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sirius Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D006951 | Hyperlipoproteinemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Drug | Administered SC. |
|
| D009750 |
| Nutritional and Metabolic Diseases |