Mild to Moderate Ulcerative Colitis
Conditions
Brief summary
To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.
Interventions
DRUGSPH3127 Tablets with Dose A
See Arm description
DRUGSPH3127 Tablets with Dose B
See Arm description
DRUGSPH3127 Tablets placebo
See Arm description
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 - 75 years, male or female; 2. Subjects who have been diagnosed with ulcerative colitis； 3. 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; 4. 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
1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis; 2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects; 3. 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; 4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts; 5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening; 6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom remission rate | Week8 | Symptom remission rate |
| Endoscopic remission rate | Week8 | Endoscopic remission rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | Week8 | Clinical remission rate |
| Symptom remission rate | Week2、Week4 | Symptom remission rate |
| Safety and tolerability since the start of any study treatment. | Approximately 3 months | Incidence of adverse event and serious adverse event , correlation with study drug |
Countries
China
Outcome results
None listed