A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 in Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 in Healthy Subjects

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: HRS4800
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide a written informed consent Males and females aged between 18 years and 55 years at screening, inclusive. Meet the weight standard Agree to take effective contraceptive methods No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests Exclusion Criteria: Severe infections, injuries or surgeries or plan to undergo any surgeries. ALT, AST, ALP or total bilirubin level abnormal Estimated Glomerular Filtration Rate (eGFR, using CKD-EPI Creatinine Equation) is abnormal 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. Subjects with cardiac and Cerebrovascular Disease Positive nicotine test History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks Positive drug screening tests Positive infectious diseases screening tests plan to use of any other medicine during the trial Whole blood donation or loss of more than 200 mL of blood within 1 month blood transfusion in the past 2 months History of allergy to the study drug or any component of it. Can't accept assigned meals during the trial Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing. poor tolerance or difficult for vein blood collection Other conditions or laboratory abnormality that may increase the risk associated with study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HRS4800 Tablet compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: HRS4800<br>* HRS4800<br>|
| Placebo Comparator: Treatment group B<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, Peak Concentration; |  | Day1 | 
| AUC0-tau, Area under the curve during a dose interval; |  | Day1 | 
| 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 | 
| Rac, , accumulation factor; |  | Day14 | 
| 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 |