Inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Conditions
Interventions
Experimental group:GD-N2203 Enemas
Control group:Placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and provide signed and dated informed consent; 2. Male or female healthy subjects aged 18 to 55 years old (including cut-off value) at the screening visit; 3. The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg. Body mass index in the range of 18.5~28.0kg/m^2 (including the cut-off value); 4. According to the results of digital rectal examination and stool examination, the subject's rectum and anus are in a healthy state; 5. The subject's intestinal tract is in a healthy state based on medical history and normal bowel movements (=3 times per week); 6. For female subjects, one of the following conditions is sufficient: (1) Not of childbearing potential, including surgical sterilization (documented tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 weeks prior to the screening visit, and menopause >=12 months prior to the screening visit; (2) Be of childbearing potential, must be non-pregnant, non-lactating, and must agree to use non-pharmacological contraception for 14 days prior to dosing, during the study, and for 3 months post-dose, and have a negative human chorionic gonadotropin (HCG) test at the screening visit and D-1; Subjects are not allowed to donate eggs during this period; 7. For male subjects with female partners of childbearing potential, must agree to use non-pharmacological contraception for 14 days prior to dosing, during the study and for 3 months after dosing. Male subjects are not allowed to donate sperm during this period; 8. Willing to comply with visits, study treatments, laboratory tests, and other study-related procedures and requirements specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug or its excipients, or a history of severe allergies (including any food allergies or drug allergies); 2. Prior presence of any disease or physical condition such as significant central nervous system, respiratory system, cardiovascular system, digestive system, hematologic system, endocrine system, musculoskeletal disease, urinary system or tumor, or any existing acute disease, or other disease or physical condition that, in the judgment of the investigator, may affect the study or pose an unacceptable risk to the subject; 3. Relevant present and past medical history judged by the investigator to affect the retention of enema fluid in the body, including hemorrhoids, anal fissures, fistulas, structural abnormalities and other diseases; 4. Patients with a history of gastrointestinal diseases (such as Hirschsprung's disease, intestinal obstruction, gastrointestinal bleeding, gastrointestinal perforation, gastroesophageal reflux disease, history of inflammatory bowel disease, etc.) or those who currently have clinically significant gastrointestinal diseases or symptoms, such as nausea, vomiting, constipation, diarrhea, etc., or those who have undergone gastrointestinal surgery; 5. Those who have a history of congestive heart disease, renal impairment, electrolyte disorders, or are taking drugs (such as diuretics) that may affect electrolyte levels; 6. Those who have malignant tumors (excluding resected non-melanoma skin cancer) within 5 years before screening; 7. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis C antibody (HCV-Ab), or positive for human immunodeficiency virus antibody (HIV-Ab), or positive for Treponema pallidum antibody (TP-Ab); 8. Body temperature >=37.3°C, obvious abnormal breathing and the investigator considers it unsuitable to participate in the trial, sitting systolic blood pressure > 140mmHg or 90mmHg or 100 beats/min, and judged by the investigator to be clinically significant; 9. The results of physical examination or laboratory examination specified in the program, or imaging examination items are abnormal and clinically significant; 10.12 Abnormal lead ECG, such as: QTcF interval (Fridericia's correction) >450 ms in males and >470 ms in females, and clinically significant; 11. Serum creatinine clearance (Ccr) < 80mL/min (calculated according to the Cockcroft-Gault formula); 12. Known or suspected history of drug abuse, or positive drug screening test at baseline; 13. Alcohol abuse within 1 year prior to screening (drinking more than 21 standard units per week, 1 standard unit containing 14g of alcohol, such as 360mL of 5% beer, 45ml of 40% spirits, 150mL of 12% wine), or a positive alcohol breath test in the baseline period; 14. Those who have difficulty in needle sickness or blood collection; 15. Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to comply with the smoking ban during the study; 16. Do not agree or cannot guarantee that you will not ingest any caffeine or xanthine-producing foods or beverages (such as coffee, tea, chocolate) containing or metabolizing after 48 hours before the first dose of the trial to the completion of the last pharmacokinetic blood sample collection; 17. Received any vaccine within 30 days prior to screening, or plans to receive any vaccine during the study; 18. During the period from 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactMiao Jia, Wang Yufang
West China Hospital of Sichuan University
Outcome results
None listed