The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS9950. The study will be conducted in three parts sequentially: Part 1, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of single doses and multiple dose of HRS9950 tablet in healthy subjects. Part 1 will consist of 84 healthy subjects, 8 groups.There will be 14 subjects in 0.75mg dose group,10 subjects in each other dose group . Part 2, evaluate food effect of HRS9950 in healthy subjects. Part 2 will consist of 14 healthy subjects, 1 group (one of groups in Part 1). Part 3, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS9950 tablet in naive and treatment-experienced chronic hepatitis B (CHB) patients. Part 3 will consist of 60 CHB patients, 1 group for naive patients and 5 groups for treatment-experienced patients.
Age range
18 Years – 65 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: 8 DAYS for Group A-M; 29 DAYS for Group F; 50 DAYS for Group G-O
Maximum Plasma Concentration [Cmax]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22
Area under the concentration time curve [AUC]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22
Time to maximum plasma concentration [Tmax]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22
Apparent clearance [CL/F]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22
Half-time [t1/2]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22
Apparent volume of distribution [Vz/F（Vd）]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22
Mean residence time [MRT]
Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22
The concentration of IL-12p40 in the serum
Timeframe: 0-48 hours after each dose for Group A-E、G-O