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The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7156 | Experimental |
| |
| HRS-7156 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7156 | Drug | HRS-7156, specified dose on specified day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event (AE) and serious adverse event (SAE) | Safety: Incidence of adverse event (AE) and serious adverse event (SAE). | Up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) | Pharmacokinetics (PK) parameter of HRS-7156. | Day 1 - Day 9. |
| Maximum Plasma Concentration (Cmax) | Pharmacokinetics (PK) parameter of HRS-7156. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaiyun Zhang | Contact | +86-0518-82342973 | kaiyun.zhang.kz38@hengrui.com | |
| Sheng Qi | Contact | +86-0518-82342973 | sheng.qi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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HRS-7156 compared with placebo.
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| HRS-7156 placebo |
| Drug |
HRS-7156 placebo, specified dose on specified day. |
|
| Day 1 - Day 9. |
| Time to maximum plasma concentration (Tmax) | Pharmacokinetics (PK) parameter of HRS-7156. | Day 1 - Day 9. |
| Renal clearance (CLR) | Pharmacokinetics (PK) parameter of HRS-7156. | Day 1 - Day 2. |
| Renin concentration of HRS-7156 | Pharmacodynamics (PD) endpoint of HRS-7156. | Day 1 - Day 9. |