IBS
Conditions
Interventions
SAD cohort 1:6 subjects were given a single low-dose of SMP-100 tablets and 2 were given placebos
SAD cohort 2:6 subjects were given a single medium-dose of SMP-100 tablets and 2 were given placebos
SAD cohort 3:6 subjects were given a single high-dose of SMP-100 tablets and 2 were given a placebos
MAD cohort 1:6 subjects were given low-dose SMP-100 tablets for 7 consecutive days, and 2 were given placebos
MAD cohort 2:6 subjects were given high-dose SMP-100 tablets for 7 consecutive days, and 2 were given placebos
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary and capable of consent. 2) Male or female, aged between =18 and =55 years old. 3) BMI =19.0 and =26.0 kg/m2 and body weight =50.0 kg for males and =45.0 kg for females. 4) Females of childbearing potential and male subjects must be willing to use one of the effective contraceptive methods throughout the study and for 180 days after (the last) study drug administration. Male subjects must be willing not to donate sperm until 180 days following the last study drug administration. 5) Be able to communicate well with
Exclusion criteria
Exclusion criteria: 1) During the screening period, any clinically significant abnormality at physical examination, vital signs, laboratory tests, Chest X-Ray, Abdominal ultrasound; 2) Clinically significant ECG abnormalities (QTcF >450 msec for males and QTcF >470 msec for females). 3) Any positive test for hepatitis B, hepatitis C, Treponema pallidum or HIV found during medical screening. 4) Positive urine cotinine test. 5) Positive alcohol breath test 6) Positive urine drug screen 7) Positive serum pregnancy test at screening. 8) Clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease and are not suitable to participate in the study after evaluation by the investigator; 9) Clinically significant illness and surgery within 12 weeks prior to dosing. 10) History of allergic reactions to SMP-100 or other related drugs, or to any excipient in the formulation. History of hypersensitivity to 5-HT3 receptor antagonists or agonists. 11) Clinically significant history of irritable bowel syndrome (IBS) of any type. Current or history of ischemic colitis. 12) Diarrhea or constipation for 1 consecutive week during the screening period and within 3 months prior to screening. Diarrhea refers to the frequency of defecation > 3 times/day, and Bristol stool score was 7. Constipation refers to the frequency of defecation =3 times/week, Bristol stool score is 1 or 2; 13) Have special requirements for diet, or cannot comply with a unified diet; or have difficulty swallowing; 14) Have difficulty in blood collection or cannot tolerate venipuncture, or have a history of fainting with needles and blood phobia; 15) Donation or loss of blood = 400 mL of blood within 3 months prior to screening. Or received blood transfusion, or donation or loss of blood =200 mL of blood within 1 month prior to screening, or planned to donation during the study or within 3 months after the end of the study; 16) Smoked more than 5 tobacco per day within 3 months prior to screening, or could not stop smoking during the whole study period; 17) Regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of mid strength beer, or 45 mL of 40% alcohol]). 18) Regular use of excessive tea, coffee or caffeinated beverage (more than 8 cups a day, 1 cup = 200 mL) ,or regular use of excessive containing caffeine, alcohol, xanthine or grapefruit food within 1 year prior to the screening visit 19) Use of any drugs (including prescription medications, over-the-counter products, natural health products and vaccines) within 14 days prior to the screening visit ; 20) History of drug abuse or dependence within 1 year prior to the screening; 21) Breast-feeding subject. 22) Participation in a clinical research study involving the administration of an investigational drug or device within 3 months prior to screening. 23) Employees or related persons of investigators, research centers, sponsors and contract research organizations; 24) Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAD blood PK Endpoint;MAD blood PK Endpoint;single dose of 4mg urine PK;single dose of 4mg feces PK; | — |
Countries
China
Contacts
Public ContactQing He
Wuxi People's Hospital
Outcome results
None listed