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Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]HLX208.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]HLX208 | Experimental | Single oral dose of 450mg [14C]HLX208 suspension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HLX208 | Drug | Carbon-14 labeled HLX208 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity in urine and fecal samples. | Mass balance recovery of total radioactivity in urine and fecal samples. | Up to 336 hours post dose. |
| Total radioactivity in plasma PK: Cmax | Maximum plasma concentration | Up to 240 hours post dose. |
| Total radioactivity in plasma PK: Tmax | Time for Cmax | Up to 240 hours post dose. |
| Total radioactivity in plasma PK: AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | Up to 240 hours post dose. |
| Total radioactivity in plasma PK: AUC0-∞ | Area under the plasma concentration time profile from time 0 to infinity. | Up to 240 hours post dose. |
| Total rradioactivity in plasma PK: t1/2 | Elimination half-life. | Up to 240 hours post dose. |
| Total radioactivity in plasma PK: CL/F | Drug clearance. | Up to 240 hours post dose. |
| Total radioactivity in plasma PK: Vz/F | Apparent volume of distribution following oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| HLX208 and metabolite PK: Cmax | Maximum plasma concentration | Up to 240 hours post dose. |
| HLX208 and metabolite PK: Tmax | Time for Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, Dr. | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| Up to 240 hours post dose. |
| Up to 240 hours post dose. |
| HLX208 and metabolite PK: AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | Up to 240 hours post dose. |
| HLX208 and metabolite PK: AUC0-∞ | Area under the plasma concentration time profile from time 0 to infinity. | Up to 240 hours post dose. |
| HLX208 and metabolite PK: t1/2 | Elimination half-life. | Up to 240 hours post dose. |
| Adverse events | Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug. | Screening up to Day 15 |