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This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level:A | Experimental | Subject will receive [14C]HRS-9057 at dose level A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HRS-9057 | Drug | [14C]HRS-9057 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period | From Day 1 to Day 28 | |
| Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC) | From Day 1 to Day 8 | |
| The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose) | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2 | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC | From Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax | From Day 1 to Day 28 | |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax | From Day 1 to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Si Chen | Contact | 0518-82342973 | si.chen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital ) | Nanjing | Jiangsu | 210036 | China |
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| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2 | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC | From Day 1 to Day 28 |
| Serious adverse events | From ICF signing date to Day 28 |