New pill for gut disease passes first safety check in healthy volunteers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet all of the following criteria to be included in the study: Demography 1. Healthy volunteers aged between 18 and 50 years old, both male and female, are required. Participants must undergo medical history investigation, physical examination, vital signs examination, electrocardiogram, chest X-ray examina-tion, and laboratory tests during the screening period to ensure good health. 2. The body mass index (BMI) is between 18 and 32, calculated as: BMI= weight(kg)/ height 2(m 2); 3. Participants were required to be in a non-menstrual, non-pregnant, and non-lactating period during the trial and to agree to have no childcare plans for the next 6 months. 4. Physical health, defined as: detailed and clear medical history, comprehensive physical examination (including blood pressure and pulse rate, laboratory tests, and 12-lead electrocardiogram) with no clinical abnormalities detected; 5. After 10 minutes of supine position testing, vital signs should be within the following range: 95 mmHg \<systolic blood pressure (SBP) \<140 mmHg 45 mmHg \<Diastolic Blood Pressure (DBP) \<90 mmHg 45 bpm \<Heart Rate (HR) \<90 bpm 6. After 10 minutes of resting supine position, 12-lead ECG readings: PR interval\<120 ms \<220 ms, QRS complex \<120 ms, QTc (Fridericia recommendedalgorithm) ≤450 ms, normal ECG; or abnormal ECG results deemed clinically insignificant by the investigator. 7. Laboratory test results must fall within the normal range (or within the established screening threshold) or show no clinically significant abnormalities; however, serum creatinine, alkaline phosphatase, and liver enzymes (aspartate aminotransferase,Alanine aminotransferase (ALT) should not exceed the upper limit of the laboratory normal range. Total bilirubin should not exceed 1.5 times the upper limit of the normal range for conjugated bilirubin (unless the subject has a history of Gilbert syndrome). 8. Willing and able to comply with all treatment, and laboratory testing protocols, agree to take the oral test medication, and meet other study requirements 9. Contraceptive requirements for female subjects: 1. Fertile female participants: Must undergo a urine pregnancy test during the screening period with a negative result, and agree to use effective contraception for 3 months after signing the informed consent until the last dose of the investigational drug. Contraception must always be strictly followed according to the instructions of the contraceptive product and the investigator. Effective contraception includes: complete abstinence, intra- uterine device (IUD) or intrauterine contraceptive system (IUS), double- barrier method (e.g., spermicide plus male condom, female condom, diaphragm, cervical cap, or intrauterine device), or a partner who has undergone vasectomy and whose semen cannot be detected for sperm. b. Fertile women: This includes postmenopausal women (with complete cessation of menstruation for ≥1 year) or women with surgical records of hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (as opposed to tubal ligation). Fertile women do not need to adhere to the listed contraceptive measures. 10. Contraceptive requirements for male subjects: Male subjects must agree to use the listed effective contraceptive methods or have undergone vasectomy within 3 months after signing the informed consent and receiving the last dose ofthe investigational drug. 11. Participants must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form. Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: Medical history and clinical status 1\. History of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, dermatological, neurological, or psychiat ric disorders. 2. Abnormal chest X-ray findings. 3. Recurrent headache and/or migraine, recurrent nausea and/or vomiting (vomiting only: more than twice a month). 4. Blood donation within 2 months prior to inclusion is permitted, with no volume restrictions. 5. Symptomatic or asymptomatic orthostatic hypotension: defined as a drop in systolic blood pressure of ≥30 mmHg within 3 minutes when changing from supine to standing position. 6. History of drug allergy or confirmed allergic disease. 7. Known to be allergic to any component ofthe pharmaceutical preparation. 8. History of drug or alcohol abuse (regular daily alcohol intake exceeding 40 mL). 9. Heavy smokers (smoking 5 or more cigarettes per day). For light smokers (smoking fewer than 5 cigarettes per day), smoking should be discontinued during the trial period. 10. Individuals who consume excessive amounts oftea or coffee (more than 8 cups per day). 11. Take any medication within 14 days before inclusion or within 5 times the half-life or pharmacodynamic half-life ofthe medication; 12. Eat any citrus fruit (e.g. grapefruit, orange) or juice in the 5 days before selection. 13. Any vaccination within 28 days prior to inclusion and any injection of a biological agent (antibody or its derivative) within 4 months. 14. According to the investigators' assessment, the subjects may have poor compliance during the study or may not be able to cooperate due to language issues or intellectual developmental delays. 15. Participants were registered or had previously participated in any other clinical study involving a drug clinical trial or any other type of medical research within 3 months prior to enrollment or within the 5 half-life period (whichever is shorter). 16. Participants who could not be contacted in an emergency. 17. Researchers or associate researchers, research assistants, pharmacists, study coordinators, or other staff members who are directly or indirectly involved in the study, or anyone associated with the study site (including employees or immediate family members). 18. Any of the following tests are positive: hepatitis B surface antigen (HBsAg), hepatitis B core antigen (anti-HBcAg), anti-HCV antibody, anti-human immunodeficiency virus 1 and 2 antibody (anti-HIV1 and anti-HIV2 Ab), or Treponema pallidum antibody. 19. Positive urine drug screening (amphetamines/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opioids). 20. Alcohol test positive. 21. Subjects with difficulty in venous blood collection.