drug-resistant tuberculosis
Conditions
Interventions
Group 1:50 mg OTB-658
Group 2:150 mg OTB-658
Group 3:300 mg OTB-658
Group 4:600 mg OTB-658
Group 5:900 mg OTB-658
Group 6:1200 mg OTB-658
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<=28kg/m^2; 5. Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. The following diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) with other clinical findings showing clinical significance within 12 months before screening . 2. Have a history of allergy to the test drug or its excipients, allergic constitution (multiple drugs and food allergies). 3. Have taken any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 14 days prior to screening. 4. Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 2 weeks before screening, or have other factors that affect drug absorption, distribution, metabolism, and excretion. 5. Recent major changes in eating or exercise habits. 6. Subjects who cannot tolerate standard meals (two boiled eggs, a piece of butter bacon toast, a box of fried potato chips, a glass of whole milk) . 7. Participated in any drug clinical trial as a subject within 3 months before participating in this trial. 8. Blood donation or massive blood loss (>450 mL) within 3 months prior to screening. 9. Those who smoked more than 5 cigarettes per day in the 3 months before the test, or who could not comply with the prohibition of smoking during the test. 10. Those with a history of drug use or drug abuse with a positive urine screening test. 11. History of alcohol abuse (14 units of alcohol per week: 1 unit = 357mL of beer with 5% alcohol or 45mL of spirits with 40% alcohol or 147mL of wine with 12% alcohol), or subjects were unwilling to stop drinking alcohol from 24 hours before the start of the study to the end of the study, or had a positive alcohol breath test. 12. Acute disease or concomitant medication occurred from the screening stage to before the study medication. 13. Consumed chocolate, any caffeinated or xanthine-rich food or beverage 48 hours prior to study drug administration. 14. Those who have special requirements for diet and cannot comply with the unified diet. 15. History of dysphagia or any gastrointestinal disease that affects drug absorption. 16. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers. 17. Abnormal ECG has clinical significance. 18. Those who cannot tolerate venipuncture for blood collection or have poor peripheral venous access conditions. 19. Pregnant, lactating subjects or those with positive blood HCG test. 20. The subjects or their partners are unwilling to use medically effective contraceptive methods for contraception during the trial, and those who have a birth plan within six months. 21. Positive screening for viral hepatitis (including hepatitis B and C), HIV antibodies, and Treponema pallidum antibodies. 22. Subjects who are considered by the investigator to 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;urine drug concentration;faeces drug concentration; | — |
Countries
China
Contacts
Public ContactYou Feng
Peking Union Second Phaemaceutical Factory
Outcome results
None listed