Ulcerative colitis (UC)
Conditions
Interventions
Single Ascending Dose Group:JMKX000189 tablets or placebo were administered once on an empty stomach on Day 1 (D1)
Food Effect Group:On day 1 of the first cycle (D1), JMKX000189 tablets were taken on an empty stomach or postprandial condition for a cleansing period of at least 14 days. Subjects were re-admitted to
Multiple Ascending Dose Group:Titrate from 1mg to 3mg, 4 mg, and 5mg
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, subjects aged 18-45 years (including 18 and 45 years); 2. The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = weight (kg)/height ^2 (m^2), BMI in the range of 18.0 to 26.0 kg/m^2 (including the critical value); 3. No abnormality or no clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, heart color ultrasound, chest radiograph/chest CT, abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney) examination or eye examination during the screening period; The subjects' pulse rate was >=60 beats/min. 60<= heart rate <=100 times/min, and three consecutive QTc tests, each QTcF<450 ms (corrected by Fridericia formula); 4. The subject (including the partner) is willing to voluntarily take effective contraceptive measures within 6 months after the last trial drug (study drug/placebo) administration; 5. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; Ability to complete research according to test protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of cardiovascular disease or arrhythmias (including but not limited to sinus atrial block, atrioventricular block, bradycardia, atrial flutter or atrial fibrillation, ventricular arrhythmia, cardiac arrest, etc.); 2. Patients with malignant tumor or history of malignant tumor; 3. A history of skin cancer or suspected skin cancer-related lesions, including melanoma, basal cell carcinoma or squamous cell carcinoma; 4. In the 12 months prior to screening, patients with diseases of digestive, cardiovascular, urinary, oncological, neurological, psychiatric, endocrine, immune, or hemolymph (such as polycythemia vera, sickle cell disease, or dysplasia of bone marrow) systems deemed by the investigator to be clinically significant that may affect the study or received major surgical operations that the researchers judged might affect the study (difficult and complicated operations such as gastric and duodenal operations, partial nephrectomy, radical resection of malignant tumors, etc.; excluding diagnostic surgical procedures) and those who have received transfusions of blood or blood components, or who are expected to undergo major surgical procedures during the study period that the investigator has determined may have an impact on the study; 5. Patients with a history of gastrointestinal surgery or excision that may affect the absorption and/or elimination of oral drugs; 6. Known history of recurrent or chronic infections judged by researchers within 3 months prior to screening, including but not limited to chronic urinary tract infections such as recurrent urinary tract infections, chronic respiratory tract infections such as bronchiectasis and chronic sinusitis, skin and soft tissue infections such as open drainage or skin infected wounds; Or acute infections, including but not limited to respiratory tract infections, infectious diarrhea, or associated drugs, that were judged by researchers to have affected the study within 7 days prior to screening; 7. Patients with history of herpes simplex, herpes zoster or chickenpox within 3 months before screening; 8. Those who have received any vaccine within 1 month prior to screening; 9. Patients who are allergic to the main ingredients and excipients of JMKX000189 tablets, or allergic to multiple drugs and food; 10. Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 28 days before screening; 11. Those who have taken special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise within 24 hours before administration (study drug/placebo), or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 12. Inability to control the intake of any food or drink (e.g., coffee, tea, chocolate) containing or metabolically producing caffeine or xanthine from 48 h before administration until completion of the last pharmacokinetic blood sample collection; 13. Patients are at risk for tuberculosis (TB), especially if they have currently clinically, radiologically or laboratory-proven active TB; Latent TB that has not been successfully treated; TB infected T cells tested positive at screening or within 6 months prior to administration; 14. Those who have one or more positive hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody; 15. Female patients were lactating or had positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Lymphcytes counting;Hematology;Blood chemistry;Urinalysis;Coagulation panel; | — |
Countries
China
Contacts
Public ContactZhang Ying
Shanghai Jemincare Pharmaceutical Co., LTD
Outcome results
None listed