New drug TJ0113 tested in healthy people for first time

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily participate in the clinical trial, sign the informed consent form, understand and agree to follow the protocol, have a full understanding of trial contents, process, and possible adverse reactions, and indicate the date of signing; 2. Aged 18 \~ 55 years (inclusive), Chinese healthy male or female; 3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female), body mass index (BMI) within the range of 19.0 \~ 26.0 kg/m2 (inclusive); 4. Subjects and their partners have no plans for pregnancy, donation of sperm or eggs, and voluntarily take effective contraceptive measures (such as abstinence, condom, etc.) from the screening phase until 6 months after the end of the trial; 5. Able to communicate well with the investigator, understand and agree to follow all requirements of this trial. Exclusion Criteria: 1. Subjects with a history or current presence of chronic diseases involving the cardiovascular, respiratory, urinary, nervous, psychiatric, hematological, endocrine and metabolic (diabetes, thyroid disease, adrenal disease), and immune systems, and deemed unsuitable for participation by the investigator. 2. Subjects who have received surgery within 3 months before screening, or plan to receive surgery during the trial; or have received medical or surgical treatment (such as gastrointestinal surgery) permanently changing the absorption, distribution, metabolism and excretion of oral drugs (except for hernia repair); a history of abdominal surgery, such as cholecystectomy (except for uncomplicated appendectomy and endoscopic treatment of gastrointestinal polyps after 6 months); 3. Subjects with dysphagia or gastrointestinal, liver, or kidney diseases (regardless of whether they have been cured) within 6 months before screening that could affect drug absorption or excretion; 4. History of clinically significant drug allergy or specific allergic diseases (such as asthma, urticaria) or known hypersensitivity to the investigational product or its excipients; 5. Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or supplements within 14 days before the first dose; 6. Subjects with abnormal and clinically significant results on physical examination, vital signs, laboratory tests (blood routine test, urinalysis + specific gravity, blood biochemistry, coagulation function, etc.) at screening and baseline; 7. Subjects with clinically significant 12-lead ECG abnormalities at screening or baseline, or with an average QTcF (corrected QT interval using Fridericia's formula) \>450 ms for males, \>470 ms for females, QRS \>120 ms, or a history of long QT syndrome. 8. Subjects who have special dietary requirements and cannot abide by the standard diet; 9. Subjects who are difficult to collect blood samples or cannot tolerate venipuncture, and have a history of fainting at the sight of blood or needles; 10. Subjects who have blood donation or non-physiological blood loss ≥ 400 mL (including trauma, blood collection, blood donation, etc., except for physiological blood loss in females) within 3 months before screening, or blood transfusion; or blood donation or non-physiological blood loss ≥ 200 mL within 1 month before screening; or blood donation or blood components planned during the study or within 3 months after the end of the study; 11. Subjects who have excessively used nicotine products (more than 5 cigarettes in average daily) within 3 months before screening and cannot stop using any tobacco products throughout the trial; subjects with positive urine cotinine tests; 12. Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), have a positive alcohol breath test at baseline (breath alcohol content \>0.0 mg/100 mL), or cannot abstain from alcohol during the trial; 13. Subjects who have long-term excessive consumption of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 200 mL) within the year prior to screening; subjects who have consumed any foods or beverages containing caffeine, alcohol, xanthine, or grapefruit components, or other substances that affect drug absorption, distribution, metabolism, and excretion (such as coffee, tea, chocolate, etc.) within 48 hours before the first dose; 14. Subjects who have received live vaccine inoculations within 14 days before screening or plan to receive them during the trial or within 1 month after dosing, including but not limited to measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin Vaccine (BCG), typhoid vaccine, COVID-19 vaccine, etc.; 15. Subjects who have febrile illness or active infection within 14 days before screening; 16. Subjects who have used any known hepatic enzyme inducers or inhibitors within 30 days before the first dose; 17. Subjects with drug addiction or positive drug abuse tests, or a history of drug abuse/dependence or drug use within 1 year before screening; 18. Subjects with positive results on infectious disease screening, including positive human immunodeficiency virus (HIV) antigen/antibody, positive hepatitis B surface antigen (HBsAg) quantification, positive hepatitis C virus (HCV) antibody, positive Treponema pallidum antibody tests; 19. Subjects with positive pregnancy tests at screening or baseline, who are pregnant, breastfeeding, or planning to become pregnant during the trial, or men or women of childbearing potential who are unwilling to use effective contraception for 6 months after the last dose; 20. Subjects who are unable to comply with all requirements of the study or still need to engage in or plan to participate in strenuous physical activity or exercise during the trial, including body contact or collision sports; 21. Subjects who have participated in other clinical trials of drugs or medical devices within 3 months before screening, and received investigational products or medical devices; or planned to participate in other trials during the study period; or within 5 half-lives of another drug before screening (if 5 half-lives exceed 3 months); 22. Employees or related personnel of the investigator, study site, sponsor, or contract research organization (CRO).Subjects who have other conditions that could impact compliance in the opinion of the investigator or who are unable to participate in the trial due to personal reasons.