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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10522 | Experimental |
| |
| HS-10522 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10522 | Drug | HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension | Safety and tolerability will be assessed by comparison of number of adverse events between groups | SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | -0.5 to 120 hour after dosing | |
| time to maximum plasma concentration (Tmax) | -0.5 to 120 hour after dosing | |
| area under the curve (AUC) |
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Inclusion Criteria:
-
For all participants:
Exclusion Criteria:
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| HS-10522 Placebo | Drug | HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily |
|
| -0.5 to 120 hour after dosing |
| half-life | -0.5 to 120 hour after dosing |
| apparent volume of distribution (Vz/F) | -0.5 to 120 hour after dosing |
| apparent oral clearance (CL/F) of HS-10522 | -0.5 to 120 hour after dosing |
| Plasma aldosterone following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing |
| Cortisol following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing |
| Metabolites levels following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing |
| (Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline | Blood pressure measurement will be performed only in MAD part | 14 days after dosing |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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