drug-resistant tuberculosis
Conditions
Interventions
Group 1 :200 mg OTB-658
Group 2:600 mg OTB-658
Group 3:Pending
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2. Able to complete the research in accordance with the requirements of the experimental plan; 3. Healthy male and female subjects aged 18 to 50 years (including 18 and 50 years old); 4. Male weight >= 50 kg, female weight >= 45 kg, calculated according to body mass index [BMI = weight (kg)/height^2(m^2)], 18 kg/m^2 <= BMI <= 28 kg/m^2; 5. Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. There are clinically significant abnormalities in clinical laboratory tests, or other clinical findings within 12 months before screening show the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung , immune, mental or cardiovascular and cerebrovascular diseases); 2. Have a history of allergy to the test drug or its excipients, and allergic constitution (multiple drug and food allergies); 3. Taking any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 14 days before screening; 4. Those who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion within 2 weeks before screening; 5. Recent major changes in diet or exercise habits; 6. Participated in any drug clinical trial as a subject within 3 months before participating in this trial; 7. Blood donation or massive blood loss (> 450 mL) within 3 months before screening; 8. Those who smoked more than 5 cigarettes per day within 3 months before the test, or who could not abide by the no-smoking regulations during the test; 9. Those who have a history of drug abuse or drug abuse urine screening positive; 10. Has a history of alcoholism (drinking 14 units of alcohol per week: 1 unit = 357 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 147 mL of wine with 12% alcohol), or Those who are unwilling to stop drinking alcohol from 48 hours before the start of the study to the end of the study, or who have a positive alcohol breath test; 11. Acute diseases or concomitant medications occurred from the screening stage to before the study medication; 12. Ingested chocolate, any caffeine or xanthine-rich food or drink 48 hours before taking the study drug; 13. Those who have special requirements for diet and cannot follow a unified diet; 14. Have dysphagia or any history of gastrointestinal diseases that affect drug absorption; 15. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; 16. Abnormal electrocardiogram has clinical significance; 17. Those who cannot tolerate blood collection by venipuncture or have poor peripheral venous access conditions; 18. Pregnant, breastfeeding women or those with positive blood HCG test; 19. Subjects or their partners who are unwilling to use medically effective contraceptive methods for contraception during the trial period, and those who have a family plan within half a year; 20. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antibody, and Treponema pallidum antibody; 21. Subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration;QT/QTc interval; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed