Pain
Conditions
Brief summary
The study is being conducted to assess the safety and tolerability of HRS4800 after multiple oral administration with different dose regimens in healthy subjects.
Interventions
DRUGHRS4800
HRS4800
DRUGPlacebo
Placebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS4800 Tablet compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Males and females aged between 18 years and 55 years at screening, inclusive. 3. Meet the weight standard 4. Agree to take effective contraceptive methods 5. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
Exclusion criteria
1. Severe infections, injuries or surgeries or plan to undergo any surgeries. 2. ALT, AST, ALP or total bilirubin level abnormal 3. Estimated Glomerular Filtration Rate (eGFR, using CKD-EPI Creatinine Equation) is abnormal 4. Subject's supine systolic BP is \>140 mmHg or \<90 mmHg; diastolic BP \>90 mmHg or \<40 mmHg at screening/baseline visits or before dosing. 5. Subjects with cardiac and Cerebrovascular Disease 6. Positive nicotine test 7. History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks 8. Positive drug screening tests 9. Positive infectious diseases screening tests 10. plan to use of any other medicine during the trial 11. Whole blood donation or loss of more than 200 mL of blood within 1 month 12. blood transfusion in the past 2 months 13. History of allergy to the study drug or any component of it. 14. Can't accept assigned meals during the trial 15. Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing. 16. poor tolerance or difficult for vein blood collection 17. Other conditions or laboratory abnormality that may increase the risk associated with study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of the Adverse Events that are related to the treatment from baseline to Day36 | from baseline to Day36 |
| The severity of the Adverse Events that are related to the treatment from baseline to Day36 | from baseline to Day36 |
Secondary
| Measure | Time frame |
|---|---|
| Tmax; The time to reach peak concentration; | Day1 |
| Css,max, Peak Concentration at steady state; | Day14 |
| AUCss, 0-tau, Area under the curve during a dose interval at steady state; | Day14 |
| AUC0-inf, Area under the curve from 0 to infinite; | Day14 |
| Tmax, the time to reach peak concentration; | Day14 |
| Ctrough trough concentration at steady state; | Day14 |
| Cmax, Peak Concentration; | Day1 |
| t1/2, terminal half life; | Day14 |
| CL/F, apparent clearance at steady state ; | Day14 |
| Vss/F; apparent volume of distribution at steady state | Day14 |
| SHR175593 concentration on Day1 and day 14 | Day1 and day 14 |
| QTc on Day1 and Day 14 | Day1 and day 14 |
| Rac, , accumulation factor; | Day14 |
| AUC0-tau, Area under the curve during a dose interval; | Day1 |
Countries
China
Outcome results
None listed