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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
\[14C\]HRS-9057
First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
Nanjing, Jiangsu, China
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
Time frame: 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)
Time frame: 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)
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax
Time frame: From Day 1 to Day 28
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Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC
Time frame: From Day 1 to Day 28
Serious adverse events
Time frame: From ICF signing date to Day 28