A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: HRS4800 tablets
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent. Male aged between 18 years and 55 years at screening, inclusive. Total body weight ≥50 kg at screening, and body mass index (BMI) between 19.0 and 26.0 kg/m2, inclusive. Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator. Exclusion Criteria: History of severe digestive system disease or having a digestive disease currently within 3 months of screening or before first dosing, and may affect drug absorption or have safety risks. Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial. ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits. Subject's supine systolic BP is ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg at screening or before first dosing. Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits. Positive drug screening tests,. Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or received blood within 2 months prior to dosing. History of allergy to the study drug or any component of it.

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HRS4800 tablets single administration in healthy male
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS4800 tablets<br> | Drug: HRS4800 tablets<br>* Drug: HRS4800 tablets Low-dose group, single oral administration Drug: HRS4800 tablets Low-medium dose group, single oral administration Drug: HRS4800 tablets medium -dose group, single oral administration Drug: HRS4800 tablets Medium and high dose group, single oral administration Drug: HRS4800 tablets High-dose group, single oral administration<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Drug: placebo Low-dose group, single oral administration Drug: placebo Low-medium dose group, single oral administration Drug: placebo medium -dose group, single oral administration Drug: placebo Medium and high dose group, single oral administration Drug: placebo High-dose group, single oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with Adverse Events (AEs) |  | 1-21 days | 
| Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities |  | 1-21 days | 
| Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities |  | 1-21 days | 
| Proportion of Participants with Vital Sign and Physical Examinations Abnormalities |  | 1-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of HRS4800, |  | 1-6 days | 
| Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800, |  | 1-6 days | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800, |  | 1-6 days | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800 |  | 1-6 days | 
| Apparent Terminal Elimination Half-Life (t1/2) of HRS4800, |  | 1-6 days | 
| Elimination Rate Constant (λz, or kel) of HRS4800, |  | 1-6 days | 
| Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800 |  | 1-6 days | 
| Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu) |  | 1-6 days | 
| Total HRS4800 of Fraction of Dose Excreted in Urine (feu) |  | 1-6 days |