InflammatoryBowelDisease,IBD
Conditions
Interventions
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants must voluntarily join this study, sign the informed consent form in person, and be capable of completing all study-related procedures and visits. 2. At screening, the age must be 18-45 years old (including the boundary values), and the participant must be male. 3. The body mass index (BMI) should be 19.0-26.0 kg/m^2 (including the boundary values), and the weight should be >= 60kg. 4. Participants must meet at least one of the following conditions: - Agree to take effective contraceptive measures throughout the study and for at least 3 months after drug administration. Additionally, have no plans to donate sperm during this period. - Males who have undergone vasectomy are exempt from the contraceptive requirement. Researchers should emphasize the importance of contraception to participants and the potential impact of unintended pregnancy.
Exclusion criteria
Exclusion criteria: 1. Severe or active lower gastrointestinal diseases and contraindications for colonoscopy: - Known or suspected gastrointestinal perforation, intestinal wall integrity impairment; - Toxic megacolon, acute severe colitis / fulminant ulcerative colitis, acute diverticulitis; - Severe uncontrolled peritonitis or sepsis; - Severe active lower gastrointestinal diseases, such as active intestinal bleeding, significant lower gastrointestinal bleeding history within the recent period (=5 years can be judged by the investigator whether to include); - Previous medical records of congenital long QT syndrome, and/or a corrected QT interval (QTcF) > 450 ms at screening or the first hospitalization check, or other clinically significant arrhythmias. 5. Previous abdominal surgery and abnormal anatomical structures - Previous colorectal resection or other major abdominal surgeries that cause significant changes in the anatomy of the colon and may affect the safety of colonoscopy or the feasibility of tissue sampling; - Other abdominal surgery history judged by the investigator to increase the risk of colonoscopy perforation, bleeding, or difficulty in operation. 6. Recent major surgery or significant blood loss - Major surgery within 4 weeks before the first dose; - Blood donation or blood loss of more than 100 mL within 2 months before the first dose, or blood donation or blood loss of more than 1.5 L within 10 months before the first dose. 7. Abnormal liver function, kidney function, and other laboratory tests - Abnormal liver function, kidney function, electrolytes, blood routine, biochemistry, coagulation function, urine routine, etc. during the screening period, judged by the in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration levels and inter-segmental distribution characteristics of TAN-118 and its main metabolites in cecal, ascending colon, transverse colon, descending colon, sigmoid colon and rectal tissues.;The concentration levels and inter-segmental distribution characteristics of TAN-118 and its main metabolites in the ascending colon, transverse colon, descending colon and sigmoid colon tissues.; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters, PD parameters and safety endpoint parameters; | — |
Countries
China
Contacts
Public ContactHongwei Fan
Nanjing First Hospital
Outcome results
None listed