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

The study is being conducted to assess the safety and tolerability of HRS4800 after multiple oral administration with different dose regimens in healthy subjects.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: HRS4800

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: HRS4800; HRS4800
Placebo Comparator: Treatment group B	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HRS4800-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No