The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
1. Drug: HRS4800 tablets Low-dose group, single oral administration 2. Drug: HRS4800 tablets Low-medium dose group, single oral administration 3. Drug: HRS4800 tablets medium -dose group, single oral administration 4. Drug: HRS4800 tablets Medium and high dose group, single oral administration 5. Drug: HRS4800 tablets High-dose group, single oral administration
1. Drug: placebo Low-dose group, single oral administration 2. Drug: placebo Low-medium dose group, single oral administration 3. Drug: placebo medium -dose group, single oral administration 4. Drug: placebo Medium and high dose group, single oral administration 5. Drug: placebo High-dose group, single oral administration
Proportion of Participants with Adverse Events (AEs)
Time frame: 1-21 days
Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Time frame: 1-21 days
Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Time frame: 1-21 days
Proportion of Participants with Vital Sign and Physical Examinations Abnormalities
Time frame: 1-21 days
Maximum Observed Plasma Concentration (Cmax) of HRS4800,
Time frame: 1-6 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,
Time frame: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,
Time frame: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800
Time frame: 1-6 days
Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,
Time frame: 1-6 days
Elimination Rate Constant (λz, or kel) of HRS4800,
Time frame: 1-6 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800
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Time frame: 1-6 days
Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)
Time frame: 1-6 days
Total HRS4800 of Fraction of Dose Excreted in Urine (feu)
Time frame: 1-6 days