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This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | HRS-5346 tablets or placebo single dose |
|
| Part 2 | Experimental | HRS-5346 tablets or placebo single dose with food effects |
|
| Part 3 | Experimental | HRS-5346 tablets or placebo multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5346 tablets | Drug | Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets | About three months from the first medication to the evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of AUC0-t of HRS-5346 in plasma and urine | About three months after the first dose | |
| Evaluation of AUC0-inf of HRS-5346 in plasma | About three months after the first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 215008 | China |
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| placebo | Drug | Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. |
|
| Evaluation of Tmax of HRS-5346 in plasma |
| About three months after the first dose |
| Evaluation of Cmax of HRS-5346 in plasma | About three months after the first dose |
| Evaluation of t1/2 of HRS-5346 in plasma | About three months after the first dose |
| Evaluation of CL/F of HRS-5346 in plasma | About three months after the first dose |
| Evaluation of Vz/F of HRS-5346 in plasma | About three months after the first dose |
| Evaluation of Ae of HRS-5346 in urine | About three months after the first dose |
| Evaluation of fe of HRS-5346 in urine | About three months after the first dose |
| Evaluation of CLR of HRS-5346 in urine | About three months after the first dose |