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The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5765 group | Experimental | Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765. |
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| HRS-5765 placebo group | Placebo Comparator | Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5765 Tablet | Drug | HRS-5765 tablet, specified dose on specified day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event (AE) | Safety parameter. | Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period). |
| Incidence of serious adverse event (SAE) | Safety parameter. | Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | PK parameter of HRS-5765. | Day 1-Day 18. |
| Maximum plasma concentration (Cmax) | PK parameter of HRS-5765. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Xu | Contact | +86 0518-82342973 | hui.xu.hx107@hengrui.com | |
| Chang Shu | Contact | +86-0518-82342973 | chang.shu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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HRS-5765 compared with placebo.
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| HRS-5765 Tablet Placebo |
| Drug |
HRS-5765 tablet placebo, specified dose on specified day. |
|
| Day 1-Day 18. |
| Time to maximum plasma concentration (Tmax) | PK parameter of HRS-5765. | Day 1-Day 18. |
| Apparent clearance (CL/F) | PK parameter of HRS-5765. | Day 1-Day 18. |