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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Pain

Treatments: Drug: HRS4800; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04991909

HRS4800-103

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: HRS4800

Treatment group B

Placebo Comparator group

Treatment:

Drug: Placebo