A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects

This is an interventional treatment trial for Rheumatoid Arthritis Read More

Inclusion Criteria:

• 1 Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
• 2 Be able to complete the research according to the requirements of the plan;
• 3 Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration;
• 4 Male and female subjects aged 18 to 55 years (including critical value);
• 5 Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, BMI in the range of 18 ~ 28 kg / m2 (including critical value);
• 6 Physical examination, normal or abnormal vital signs are of no clinical significance

Exclusion Criteria:

• 1 Those who smoke more than 5 cigarettes per day in the 12 weeks before screening;
• 2 Allergic constitution (a variety of drug and food allergies);
• 3 Have a history of substance abuse, drug and/or alcohol abuse;
• 4 Donate blood or lose a lot of blood (> 450 mL) within 12 weeks prior to screening;
• 5 Take any drug that alters the activity of liver enzymes 28 days before screening, or combined with inhibitors or inducers of Cytochrome P4503A4 enzyme (CYP3A4 );
• 6 Took any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to screening;
• 7 Those who have taken a special diet or have strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion and other factors;
• 8 Those who are vaccinated with live attenuated vaccines within 28 days before the start of research treatment, inactivated vaccines within 7 days, or vaccinated during the study period;
• 9 Have taken research drugs within 12 weeks before taking our research drugs, or participated in clinical trials of drugs;
• 10 Have a history of dysphagia or any gastrointestinal diseases that affect the absorption of the drug or a history of gallbladder resection or biliary tract diseases;
• 11 Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
• 12 Subjects who could not tolerate a standard meal; (only applies to subjects participating in the postprandial test);
• 13 Electrocardiogram (ECG) abnormalities have clinical significance;
• 14 Female subjects are breastfeeding during the screening period or during the test or have a positive serum pregnancy result;
• 15 Diseases with abnormal clinical significance in clinical laboratory examination or other clinical findings within 24 weeks before screening;
• 16 Positive screening for viral hepatitis (including hepatitis B and C), Acquired Immune Deficiency Syndrome (AIDS) antibodies, treponemal antibodies;
• 17 Acute illness or concomitant medication from the screening stage to the study of medication;
• 18 Chocolate, any caffeinated or xanthine-rich foods or beverages taken 24 hours before taking the study drug;
• 19 Have taken any products containing alcohol within 24 hours before taking the research medication;
• 20 Positive for urine drug screening;
• 21 Participants who were considered by the investigators to have other factors that were not suitable for this trial.