Tuberculosis
Conditions
Interventions
NTB-3119M tablets placebo group (Part I):NTB-3119M tablets placebo
NTB-3119M tablets group (Part 2):NTB-3119M tablets
NTB-3119M tablets group (Part 1):NTB-3119M tablets
NTB-3119M tablets group (Part 3):NTB-3119M tablets
NTB-3119M Tablets Placebo Group (Part II):NTB-3119M tablets placebo
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol; 2. Healthy male and female participants aged 18~45 years (including 18 and 45 years old); 3. Male weight >=50 kg, female weight >=45 kg, calculated according to body mass index [BMI=weight (kg)/height 2 (m^2)], 19 kg/m^2<=BMI<=26 kg/m^2; 4. The participant has no birth plan within 6 months from signing the informed consent form to the last dose of the investigational drug, no sperm donation for men and no egg donation plan for women, and voluntarily takes non-drug contraceptive measures during this period.
Exclusion criteria
Exclusion criteria: 1.Volunteers who have a history or current diagnosis of any clinically significant diseases in the cardiovascular, respiratory, genitourinary, digestive, nervous, hematological, endocrine and metabolic systems, oncology, immunology, psychiatry, or any other diseases that may interfere with the trial results as determined by the investigator. 2.Volunteers with a known or suspected history of allergy to the investigational drug or its excipients, or those with an allergic constitution (allergy to two or more medications or foods). 3.Volunteers who have undergone surgery within three months prior to screening, or who are planned to undergo surgery during the trial, or who have had surgery that may affect drug absorption, distribution, metabolism, or excretion. 4.Volunteers with a history of severe cardiovascular disease or a family history of such conditions, or a personal or family history of any cardiac conduction abnormalities, or a family history of any syndrome associated with prolonged QT interval. 5.Volunteers with a 12-lead ECG at screening showing PR > 200 ms, QRS > 110 ms, HR 100 bpm, QTcF > 450 ms, or any other 12-lead ECG abnormalities that may affect the QTc interval, such as complete right bundle branch block. 6.Volunteers with clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as determined by the investigator. 7.Volunteers who have had an acute infectious disease within four weeks prior to screening, such as acute pharyngitis, acute bronchitis, acute appendicitis, etc. 8.Volunteers who have used any prescription medications, over-the-counter drugs, herbal remedies, or dietary supplements within two weeks (or five half-lives, whichever is longer) prior to screening. 9.Volunteers who have taken any medications within four weeks prior to screening that alter the gastrointestinal environment (e.g., proton pump inhibitors such as tectoprazole, omeprazole, lansoprazole, esomeprazole; histamine receptor (H2) antagonists such as ranitidine, cimetidine, famotidine; antacids such as sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate; gastric mucosal protectants such as sucralfate) or affect the activity of CYP450 enzymes (e.g., inducers—barbiturates, carbamazepine, phenytoin, dexamethasone; inhibitors—SSRI antidepressants, ciprofloxacin, cimetidine, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, omeprazole). 10.Volunteers with abnormal and clinically significant findings in vital signs, physical examination, laboratory tests, chest X-ray, abdominal ultrasound, etc., as determined by the study physician during the screening period. 11.Volunteers with a history of drug abuse or drug use within three months prior to screening, or those with a positive urine drug screen or nicotine test. 12.Volunteers who are positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis-specific antibody at screening. 13.Volunteers with a history of alcohol abuse within three months prior to screening (consuming 14 units of alcohol per week: 1 unit = 357 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 147 mL of wine with 12% alcohol content), or those who are unwilling to abstain from alcohol for 24 hours before the start of the study until the end of the study, or those with a positive alcohol breath test. 14
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pharmacokinetic parameters of NTB-3119 and its metabolites;AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minor pharmacokinetic indicators and adverse events of NTB-3119 and its metabolites;Pharmacokinetic parameters of NTB-3119 and its metabolites; | — |
Countries
China
Contacts
Public ContactNaihui Chu ; Yu Lu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed