Clinical trial NCT04991909: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS4800 Tablet compared with placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of the Adverse Events that are related to the treatment from baseline to Day36
timeFrame: from baseline to Day36
measure: The severity of the Adverse Events that are related to the treatment from baseline to Day36
timeFrame: from baseline to Day36
Secondary outcomes:
measure: Cmax, Peak Concentration;
timeFrame: Day1
measure: AUC0-tau, Area under the curve during a dose interval;
timeFrame: Day1
measure: Tmax; The time to reach peak concentration;
timeFrame: Day1
measure: Css,max, Peak Concentration at steady state;
timeFrame: Day14
measure: AUCss, 0-tau, Area under the curve during a dose interval at steady state;
timeFrame: Day14
measure: AUC0-inf, Area under the curve from 0 to infinite;
timeFrame: Day14
measure: Tmax, the time to reach peak concentration;
timeFrame: Day14
measure: Ctrough trough concentration at steady state;
timeFrame: Day14
measure: Rac, , accumulation factor;
timeFrame: Day14
measure: t1/2, terminal half life;
timeFrame: Day14
measure: CL/F, apparent clearance at steady state ;
timeFrame: Day14
measure: Vss/F; apparent volume of distribution at steady state
timeFrame: Day14
measure: SHR175593 concentration on Day1 and day 14
timeFrame: Day1 and day 14
measure: QTc on Day1 and Day 14
timeFrame: Day1 and day 14
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: