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The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLC7401 injection | Experimental |
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| RBD7022 injection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLC7401 injection | Drug | QLC7401 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. QLC7401 injection was introduced by Qilu Pharmaceutical Co., Ltd. from Suzhou Ruibo Biotechnology Co., Ltd. QLC7401 injection was produced by Qilu Pharmaceutical Co., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration of QLC7401 and active metabolites. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
| AUC | Area under the concentration-time curve of QLC7401 and active metabolites. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
| Tmax | Time of maximum observed concentration of QLC7401 and active metabolites.. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
| t1/2 | Terminal elimination half-life of QLC7401 and active metabolites. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
| CL/F | Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
| VZ/F | Apparent volume of distribution after oral administration of QLC7401 and active metabolites. | 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, doctorate | Contact | 0532-82911767 | Caoyu1767@126.com | |
| Cheng qian Li, doctorate | Contact | 18661806523 | Lichengqian5213@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University. | Qingdao | China |
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| RBD7022 injection | Drug | RBD7022 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. RBD7022 injection was produced by Suzhou Ruibo Biotechnology Co., Ltd. |
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