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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04991909
• Other study ID #: HRS4800-103
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: August 23, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: July 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• HRS4800
HRS4800
• Placebo
Placebo

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the Adverse Events that are related to the treatment from baseline to Day36		from baseline to Day36
Primary	The severity of the Adverse Events that are related to the treatment from baseline to Day36		from baseline to Day36
Secondary	Cmax, Peak Concentration;		Day1
Secondary	AUC0-tau, Area under the curve during a dose interval;		Day1
Secondary	Tmax; The time to reach peak concentration;		Day1
Secondary	Css,max, Peak Concentration at steady state;		Day14
Secondary	AUCss, 0-tau, Area under the curve during a dose interval at steady state;		Day14
Secondary	AUC0-inf, Area under the curve from 0 to infinite;		Day14
Secondary	Tmax, the time to reach peak concentration;		Day14
Secondary	Ctrough trough concentration at steady state;		Day14
Secondary	Rac, , accumulation factor;		Day14
Secondary	t1/2, terminal half life;		Day14
Secondary	CL/F, apparent clearance at steady state ;		Day14
Secondary	Vss/F; apparent volume of distribution at steady state		Day14
Secondary	SHR175593 concentration on Day1 and day 14		Day1 and day 14
Secondary	QTc on Day1 and Day 14		Day1 and day 14