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This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1301 group | Experimental |
| |
| HRS-1301 placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1301 | Drug | HRS-1301. |
| |
| HRS-1301 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | From the first dose up to Day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| HRS-1301 plasma drug concentration. | Up to 168 hours after the first dosing. | |
| HRS-1301 urine drug concentration. | Up to 168 hours after the first dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
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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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| Drug |
HRS-1301 placebo. |
|