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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in hypercholesterolemia subjects.
Totally about 30-50 qualified subjects were assigned to one of the following dose groups:20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of the dose groups will include 10 subjects (8 for DC739 and 2 for placebo).
Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or placebo on day 1 and then treat for 28 days. Subjects from different dose groups were enrolled in turn, the next dose group is conducted on the premise that the D15 safety evaluation was completed after the administration of the previous dose group with the result was tolerance.
Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after administration for pharmacokinetic data analysis. Blood lipid will be collected for effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC371739 20mg Dose MAD | Experimental | Orally administered DC371739 tablets QD afer meal |
|
| DC371739 Placebo MAD | Placebo Comparator | Placebo orally administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC371739 Tablets | Drug | Participants received one of 5 dose levels of DC371739 administered as single oral doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| tolerability evaluation | 12-lead ECG | From informed consent until Day 42. |
| Safety evaluation | adverse events (AE/SAEs) | From informed consent until Day 42. |
| Pharmacodynamic evaluation | Cmax | From informed consent until Day 31. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective evaluation | LDL-C | From informed consent until Day 29. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35427476 | Derived | Wang J, Zhao J, Yan C, Xi C, Wu C, Zhao J, Li F, Ding Y, Zhang R, Qi S, Li X, Liu C, Hou W, Chen H, Wang Y, Wu D, Chen K, Jiang H, Huang H, Liu H. Identification and evaluation of a lipid-lowering small compound in preclinical models and in a Phase I trial. Cell Metab. 2022 May 3;34(5):667-680.e6. doi: 10.1016/j.cmet.2022.03.006. Epub 2022 Apr 14. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Participants are assigned to one of 5 groups in parallel for the duration of the study
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Participant, Investigator
| Placebo | Drug | Placebo orally administered as comparison |
|
| D009750 |
| Nutritional and Metabolic Diseases |