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The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD, SHR-1918 | Experimental | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection |
|
| SAD, SHR-1918 placebo | Placebo Comparator | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1918 | Drug | Ascending dose |
| |
| SHR-1918 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the number of subjects with adverse events (AEs) | up to day 190 | |
| To assess the number of subjects with serious adverse events (SAEs) | up to day 190 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess AUC0-t | up to day 190 | |
| To assess AUC0-∞ | up to day 190 | |
| To assess Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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1.History of disease or treatment for:
2.Any one of the following tests at screening :
3.General:
4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 511447 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576753 | Derived | Qin R, Ye L, Duan L, Li M, He W, Mei X, Li D, Jin R, Lv C, Zhu M, Wang S, Xie Z. SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Pharmacokinet. 2025 Aug;64(8):1245-1253. doi: 10.1007/s40262-025-01539-8. Epub 2025 Jun 27. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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SHR-1918 injection compared with placebo
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| Drug |
Ascending dose |
|
| up to day 190 |
| To assess Cmax | up to day 190 |
| To assess t1/2 | up to day 190 |
| To assess CL/F | up to day 190 |
| To assess 、V/F. | up to day 190 |
| To assess LDL-C | up to day 190 |
| To assess TC | up to day 190 |
| To assess HDL-C | up to day 190 |
| To assess TG | up to day 190 |
| To assess ApoB | up to day 190 |
| To assess ApoA1 | up to day 190 |
| To assess Lp(a) | up to day 190 |
| To assess VLDL-C. | up to day 190 |
| To assess ADA(or/and Nab). | up to day 190 |