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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06168929
Other study ID # SHR4640-112
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 13, 2023
Est. completion date January 13, 2024

Study information

Verified date January 2024
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 13, 2024
Est. primary completion date January 13, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. 18 years to 45 years (inclusive). 3. Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive). 4. The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance. Exclusion Criteria: 1. Pregnant or nursing women. 2. No birth control 1 weeks before screening or until one week after SHR4640 administration. 3. Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive. 4. Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening). 5. Subject with a history of substance abuse and drug abuse. 6. The investigators determined that other conditions were inappropriate for participation in this clinical trial. 7. sUA level =480 µmol/L. 8. eGFR < 90 mL/min/1.73 m2. 9. Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody, or syphilis antibody, or hepatitis B surface antigen. 10. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant. 11. Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators. 12. History of hypersensitivity to SHR4640 or its analogues. 13. History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound. 14. History of been diagnosed with acute kidney injury in the past or screening period. 15. Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study. 16. Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood > 400 mL in the 3 months prior to screening. 17. Has unsuitable venous for blood sampling. 18. Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device). 19. Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study. 20. Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration. 21. Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR4640
SHR4640, 2.5mg*4 - 10mg*1
SHR4640
SHR4640, 10mg*1 - 2.5mg*4

Locations

Country Name City State
China Central Hospital Affilated to Shandong First Medical University Jinan Shandong

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 PK parameters of SHR4640: Cmax 0 hour to 72 hour after administration
Primary PK parameters of SHR4640: AUC0-t 0 hour to 72 hour after administration
Primary PK parameters of SHR4640: AUC0-inf 0 hour to 72 hour after administration
Secondary PK parameters of SHR4640: Tmax 0 hour to 72 hour after administration
Secondary PK parameters of SHR4640: t1/2 0 hour to 72 hour after administration
Secondary PK parameters of SHR4640: CL/F 0 hour to 72 hour after administration
Secondary PK parameters of SHR4640: Vz/F 0 hour to 72 hour after administration
Secondary Adverse events from ICF signing date to approximate day 13
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