B-cell lymphoma
Conditions
Interventions
Group 1: 15mg(Including 6 participants with HBW-3220 capsules and 2 participants with placebo):The first cycle for Group 1 will involve a single dose administered on an empty stomach, while the second
the washout period between the two cycles will be at least 7 days.
Group 2: 45mg (including 6 participants with HBW-3220 capsules and 2 participants with placebo):The first cycle of Group 2 will involve a single dose administered on an empty stomach, and the second c
the washout period between the two cycles is at least 7 days.
Group 3: 90mg (including 6 participants with HBW-3220 capsules and 2 participants with placebo):The first cycle for Group 3 will involve a single dose administered on an empty stomach, while the secon
Group 4: 120mg (including 12 participants with HBW-3220 capsules and 2 participants with placebo).:Group 4 will receive a single dose on an empty stomach in the first period, and after at least 7 days
Group 5: 180mg (including 6 participants with HBW-3220 capsules and 2 participants with placebo).:Group 5 only received a single dose on an empty stomach, with no second cycle planned.
Group 6: 240mg (including 6 participants with HBW-3220 capsules and 2 participants with placebo).:Group 6 only received a single dose on an empty stomach, with no second cycle planned.
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand and voluntarily sign the informed consent form, fully understand the purpose, process and possible risks of the trial, and be willing to follow the requirements of the trial protocol; 2. Age: 18 to 55 years old (including the boundary value); 3. Male body weight > =50.0 kg, female weight > =45.0 kg. Body mass index (BMI) = weight (kg)/height (m^2). BMI should be within the range of 19.0 to 26.0kg/m^2 (including the boundary value). 4. There were no plans for having children from 2 weeks before screening to 3 months after the last administration, and they voluntarily took effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergies to two or more drugs, foods or other substances; 2. There is difficulty in venous blood collection, inability to tolerate venipuncture, or a history of fainting at the sight of needles or blood. 3. Currently suffering from or having suffered from any clinical serious diseases that may interfere with the test results, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, blood system, immune system, mental system or metabolic diseases; 4. Have heart disease Including but not limited to congenital long QT syndrome, torus cuspidata heart disease or risk factors for torus cuspidata heart disease (such as heart failure, hypokalemia, family history of long QT syndrome), current use of Class IA [such as quinidine or procaainamide] or Class III [such as amiodarone or sotalol] antiarrhythmic drugs or other drugs known to have an impact on the QT interval Or those with a QTc interval (QTcF) corrected according to Fridericia's standard at the time of screening =450 ms (for males), (QTcF) =460 ms (for females), or a PR interval > 200 ms or a QRS interval =120 ms; 5. There is a bleeding tendency or coagulation disorder (such as uncontrolled autoimmune hemolysis and thrombocytopenic purpura, severe hematopoietic dysfunction, recent gastrointestinal bleeding), or there has been a bleeding event recently; 6. Within the three months prior to screening, there have been infections that were determined to be clinically significant by the researchers, including acute and chronic infections, local infections such as sepsis, abscesses and opportunistic infections, etc. 7. Those who have undergone surgical operation within 3 months prior to the trial, or plan to undergo surgical operation during the study period; 8. Those who have taken any medication or health supplements (including Chinese herbal medicines) within 14 days prior to the test; 9. Any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) have been used within 30 days prior to the test; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines; 10. Having participated in any clinical trials and taken the investigational drugs within the three months prior to screening; 11. Having donated blood or lost blood of =400 mL (excluding menstrual bleeding in women), received blood transfusion or used blood products within 3 months prior to screening; 12. Pregnant or lactating women; During the trial period, they were unwilling to take effective non-pharmaceutical contraceptive measures. 13. Those who have special dietary requirements, cannot follow a uniform diet, or have difficulty swallowing; 14. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day; Study those who have consumed any beverages or foods rich in grapefruit or other substances that affect drug absorption, distribution, metabolism, excretion, etc. within 48 hours before the first administration of the drug; 15. Those who tested positive for nicotine before the first use of the drug, or who smoked more than 5 cigarettes per day for 3 months before the trial, or who were unable to stop using any tobacco products during the trial period; 16. Those who tested positive for alcohol before the first use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics(AUC0-tAUC0-8 Cmax AUC0-t,ssAUC0-8,ss Cmax,ss); | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital, Central South University
Outcome results
None listed