Intermediate/high-risk myelofibrosis, acute/chronic graft-versus-host disease, hemophagocytic syndrome, etc.
Conditions
Interventions
Experimental group:TQ05105 Tablet: Administer 1 dose in the morning on D1 and D8 (on an empty stomach) (On D8, take 40 mg of Rabeprazole Sodium Enteric-coated Tablets orally on an empty stomach, follo
Sponsors
Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The participants in the trial must meet all of the following criteria to be eligible: 1. Sign the informed consent form before the trial, fully understand the trial content, process and possible adverse reactions; and be able to complete the study as per the trial protocol; 2. The trial participants (including their partners) are willing to refrain from pregnancy planning, sperm donation, and egg donation for the next 6 months after the last administration of the trial medication, and voluntarily take effective contraceptive measures; 3. Healthy trial participants aged 18 to 45 years (inclusive) of either gender; Male trial participants have a body weight of no less than 50.0 kilograms, and female trial participants have a body weight of no less than 45.0 kilograms. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with a BMI within the range of 18.0 to 28.0 kg/m^2 (including the critical value).
Exclusion criteria
Exclusion criteria: Participants who meet one or more of the following criteria will be excluded: 1. Those with abnormal vital signs, physical examination results, electrocardiogram findings, or clinical laboratory tests that have clinical significance and are judged by the study doctor to be unsuitable for participating in the clinical trial; 2. Those who have had serious or chronic diseases in the past 1 year or currently have diseases in the circulatory system, digestive system, respiratory system, urinary system, nervous system, blood system, endocrine and metabolic system, tumors, immunity, or mental health, or any other diseases that may interfere with the test results; 3. Those whose platelet count and absolute neutrophil value in the blood routine test at the screening stage are lower than the lower limit of the reference value; 4. Those with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers, etc.; 5. Those whose alanine aminotransferase (ALT) is > 1.2 × the upper limit of normal (ULN), or aspartate aminotransferase (AST) is > 1.2 × ULN, or alkaline phosphatase is > 1.2 × ULN, or total bilirubin is > 1.2 × ULN, or judged by the study doctor to have clinically significant abnormalities; 6. Those who have had any malignant tumor within the past 5 years; 7. Those with conditions that may affect the absorption, distribution, metabolism or excretion of the study drug (such as inability to swallow, etc.) or those who have undergone gastrointestinal resection surgery that may affect the absorption, distribution, metabolism or excretion of the drug; 8. Those who are allergic to rabeprazole, TQ05105 or its excipient components, or have an allergic constitution (such as having an allergy to two or more substances, including a history of drug allergy, prone to rash, eczema, urticaria, asthma, etc.); 9. Those who have used any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 enzymes within 4 weeks before screening (see Appendix 2); 10. Those who have used any prescription drugs, over-the-counter drugs, herbal medicines or food supplements (such as vitamins, calcium supplements, etc.) within 4 weeks before screening; 11. Those who have received any acid-suppressing treatment within 3 months before screening; 12. Those who have participated in any drug clinical trials within 3 months before screening or during the 5 half-life period of the drug (whichever is longer) and have used any clinical trial drugs; 13. Those with positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or syphilis spirochete antibody; 14. Those with a glomerular filtration rate (GFR) of = 200 mL within 4 weeks before screening, or undergone plasma exchange; 19. Those who have consumed any food or beverage containing alcohol (or have a positive alcohol breath test), grapefruit juice/western grape juice or coffee, tea, cola, chocolate within 72 hours before administration; 20. Those
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;12-lead ECG;Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactYang Guoping; Zuo Xiaocong
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed