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

Phase 1

• Conditions: Pain
• Interventions: Drug: HRS4800; Drug: Placebo

• Registration Number: NCT04991909
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-05
• Study Start: 2021-08-23
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	HRS4800	-
Treatment group B	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China