A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
Mild to Moderate Ulcerative Colitis
About this trial
This is an interventional treatment trial for Mild to Moderate Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria: Aged 18 - 75 years, male or female; Subjects who have been diagnosed with ulcerative colitis; Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose; Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial. Exclusion Criteria: Subjects who are diagnosed with Crohn's disease or indeterminate colitis; Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects; Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period; Subjects and lactating women and those who will become pregnant within 6 months after the trial starts; Subjects with a history of drug abuse with clinical significance within 1 year prior to screening; Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.
Sites / Locations
- The First Affiliated Hospital,Sun Yat-sen UniversityRecruiting
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
- The Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Huizhou First HospitalRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Union Hospital Tongji Medical College Huazhong Universitu of Science and TechnologyRecruiting
- Tongji Hospital Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- The First Affiliated Hospital of University of South ChinaRecruiting
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
- Shengjing Hospital affiliated to China Medical UniversityRecruiting
- General Hospital of Ningxia Medical UniversityRecruiting
- Beijing Chao-Yang Hospital,Capital Medical UniversityRecruiting
- Peking University Third HospitalRecruiting
- Chifeng Municipal HospitalRecruiting
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Shanghai Jiaotong University School of Medicine, Renji HospitalRecruiting
- Tianjin Medical University General Hospital;Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
SPH3127 Tablets with Dose A
SPH3127 Tablets with Dose B
SPH3127 Tablets placebo
Oral daily dose of SPH3127 Tablets for up to 8 weeks
Oral daily dose of SPH3127 Tablets for up to 8 weeks
Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks