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The purpose of this phase â… study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo |
|
| multiple ascending dose (MAD) cohorts | Experimental | Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9813 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of adverse event (AE), serious adverse event (SAE) | 7 days (SAD), 14 days (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of HRS-9813: Area under the concentration time curve (AUC) | Days 1-9 | |
| PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax) | Days 1-9 | |
| PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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HRS-9813 compared with placebo
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| Placebo | Drug | Specified dose on specified days |
|
| Days 1-9 |
| PK parameter of HRS-9813: Half-life (t1/2) | Days 1-9 |
| PK parameter of HRS-9813: Apparent clearance (CL/F) | Days 1-9 |
| PK parameter of HRS-9813: Apparent volume of distribution (Vz/F) | Days 1-9 |
| PK parameter of HRS-9813: Accumulation ratio (Racc) | Days 1-9 |
| PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine | Days 1-2 |
| PK parameter of HRS-9813: Fractional excretion (fe) in the urine | Days 1-2 |
| PK parameter of HRS-9813: Renal clearance (CLR) | Days 1-2 |