healthy person
Conditions
Interventions
Single-dose escalation in healthy subjects group:The study prespecified five dose groups: 150 mg, 300 mg, 600 mg, 1200 mg, and 1800 mg (optional).
During the trial, single-dose escalation may be adjus
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and agree to adhere to the trial protocol; 2. Healthy males or females aged 18 to 45 years inclusive (as determined at the time of signing the informed consent form); 3. Male weight >= 50 kg, female weight >= 45 kg; Body Mass Index (BMI) = weight (kg) / height² (m²), with BMI within the range of 19 to 26 kg/m² (both endpoints inclusive); 4. No abnormalities detected during physical examination, vital signs assessment, 12-lead electrocardiogram, chest X-ray (anterior-posterior and lateral views), abdominal ultrasound, and laboratory tests during the screening and baseline periods; or minor abnormalities deemed clinically insignificant by the investigator; 5. Female subjects of childbearing potential and male subjects with partners of childbearing age must have employed effective contraception for the two weeks preceding informed consent signing. They must agree to abstain from sexual intercourse or use contraception (specific methods detailed in subsection 13.1.2) from consent signing until follow-up completion, and have no plans for conception or sperm/egg donation.
Exclusion criteria
Exclusion criteria: 1. Those who have had any diseases such as urinary system, circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, psychiatric and metabolic abnormalities and are judged by the investigator to be clinically significant; 2. The subject has any conditions or diseases that affect the absorption, metabolism, and/or excretion of the study drug as judged by the investigator; 3. Those who have had serious infections, severe trauma, or major surgery within 1 month before the screening period; or those who plan to undergo surgery during the trial; 4. Subjects who are allergic to the study drug or any component of the study drug, or have allergic constitutions (such as asthma, eczema); 5. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, dietary supplements, and vitamin A and their derivatives, etc., excluding other conventional vitamins and occasional use of acetaminophen) in the previous 2 weeks before the screening period, or those who have been within 5 half-lives of the drug during the screening period (whichever is longer), or plan to use non-investigational drugs during the trial; 6. Those who have participated in clinical trials of any other drugs or medical devices within 3 months before the screening period or plan to participate in any other drug or medical device during the study period, or those who are within 5 half-lives of the drug during the screening period (whichever is longer); 7. During the screening period or baseline period, 12-lead ECG examination showed QTcF>450 ms, or other abnormal clinically significant abnormalities judged by the study doctor; 8. During the screening period or baseline period, blood creatinine exceeded the upper limit of normal value (ULN); 9. Glomerular filtration rate (eGFR) =400 mL) within 8 weeks before the screening period, or who have received blood transfusion within 4 weeks before the screening period or baseline period; or those who intend to donate blood during the trial; 14. Vaccination within 2 weeks before the screening period or planned to be vaccinated during the trial; 15. Those who have a history of smoking abuse (an average >of 5 cigarettes per day) 4 weeks before the screening period, or those who cannot stop using any tobacco products during the trial; 16. Those who have an average daily intake of more than 15 g of alcohol (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or about 50 mL of low-alcohol liquor) within 4 weeks before the screening period, or those who cannot abstain from alcohol during the trial; or those who have a positive alcohol breath test at baseline; 17
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;health checkup;laboratory inspection;12-lead electrocardiogram;pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactFeng Ping
West China Hospital, Sichuan University
Outcome results
None listed