NTQ6179 tablets first-in-human test in healthy adults

Inclusion Criteria:

1. Healthy males or females aged ≥ 18 and ≤ 55 years (both inclusive).
2. Women must be non-pregnant and non-lactating; postmenopausal status according to medical history confirmed by follicle-stimulating hormone (FSH) \> 40 U/L at screening, or surgical sterilization.
3. Body mass index (BMI) between 19.0 and 26.0 kg/m2 (both inclusive) at screening, with a body weight ≥ 50 kg for males and ≥ 45 kg for females.
4. Full understanding of the study and voluntary signing of the informed consent form (ICF) before undergoing any study-specific procedures.
5. Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Participation in any other drug clinical trial and use of the investigational product within 3 months prior to admission.
2. Chronic or active gastrointestinal diseases (e.g., esophageal diseases, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, or active gastrointestinal bleeding) or gastrointestinal surgery within 3 years prior to admission, with clinically significant conditions at present as judged by the investigator.
3. Definite diseases of the nervous, cardiovascular (e.g., heart disease, arrhythmia, etc.), digestive, respiratory, endocrine, urinary, hematological, immune, or reproductive systems, or metabolic disorders, or other diseases requiring medical intervention or unsuitable for the clinical trial (e.g., history of psychiatric disorders).
4. Any neuroendocrine tumors and related diseases (including but not limited to acromegaly, growth hormone deficiency, carcinoid syndrome, and Cushing's syndrome).
5. Past or current thyroid dysfunction, cholelithiasis or complications of cholelithiasis, pancreatic exocrine insufficiency (e.g., steatorrhea, impaired absorption of dietary fat, pancreatic injury, pancreatitis, etc.) and related diseases.
6. Past or current glucose metabolism disorders (e.g., hypoglycemia, hyperglycemia, diabetes mellitus, impaired glucose tolerance, etc.).
7. Diarrhea, abdominal pain, nausea, headache, dizziness, or arthralgia within 7 days prior to admission.
8. Allergy to the investigational formulation and any of its components or related formulations, or a history of allergy to drugs, foods, or other substances.
9. Inability to tolerate venipuncture, or a history of hemophobia or needle phobia.
10. Surgery judged by the investigator to affect drug absorption, distribution, metabolism, or excretion within 6 months prior to admission; or surgery within 4 weeks prior to admission; or planned surgery during the study period.
11. Use of any medications (including prescription drugs, over-the-counter drugs, herbal medicines, Chinese patent medicines, and dietary supplements, etc.) within 14 days prior to admission; or within 5 half-lives of the medication at screening (whichever is longer).
12. Vaccination or live attenuated vaccine administration within 14 days prior to admission, or planned vaccination during the study period.
13. QTcF \> 450 msec for males or QTcF \> 470 msec for females at screening.
14. Blood donation or massive blood loss (\> 400 mL) within 3 months prior to admission, or receipt of blood transfusion or blood products; or intention to donate blood or blood components during the study period or within 3 months after the end of the study.
15. Drug abuse, or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to admission; or a positive urine drug screening test.
16. Smoking habit, or smoking within 3 months prior to admission, or inability to abstain from any tobacco products during the study period; or a positive urine cotinine test.
17. Alcohol abuse, or regular alcohol consumption within 6 months prior to admission (i.e., \> 14 units of alcohol per week; 1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine); or unwillingness to abstain from alcohol or any alcohol-containing products during the study period; or a positive breath alcohol test.
18. Inability to comply with the prohibition of tea, coffee, and other caffeinated or alcoholic beverages, smoking, and strenuous exercise throughout the study period.
19. Consumption of a diet that may affect drug metabolism in vivo (including grapefruit or grapefruit products, etc.) within 7 days prior to admission; or other diets that, in the opinion of the investigator, may affect drug absorption, distribution, metabolism, or excretion; or unwillingness to abstain from such diets during the study period.
20. Special dietary requirements or inability to comply with the standardized diet.
21. The participant (or their partner) with plans for pregnancy, sperm or oocyte donation, or sperm or oocyte cryopreservation from the signing of the ICF until 3 months after the last dose; or unwillingness to adopt one or more non-pharmacological contraceptive measures (e.g., complete abstinence, intrauterine device, or partner sterilization, etc.).
22. Clinically significant abnormalities in vital signs, physical examination, laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function panel (5 items), insulin, glucagon, serum adrenocorticotropic hormone \[ACTH\], prolactin, pancreatic enzymes \[pancreatic amylase and pancreatic lipase\]), the four tests for transfusion safety, 12-lead electrocardiogram, chest posteroanterior radiograph, abdominal ultrasound, echocardiography, or pregnancy test (females only) at screening or admission, as judged by the investigator.
23. Creatinine clearance \< 80 mL/min.
24. Any other circumstances that may prevent the participant from completing the study, or unsuitability for the trial as judged by the investigator.