This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.
Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).
Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration and have no sperm or egg donation plan during the study period and within 3 months after the last dose.
Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.
Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol.
Subjects have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease associated with colitis, enterophthisis, abdominal abscess or fistula, etc.
Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study.
Subjects have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days prior to the screening endoscopy or have tested positive for Clostridium Difficile toxins or other intestinal pathogens at the screening period.
Parallel
ISM5411 tablets
DrugDosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tablets
DrugDosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tablets
DrugDosage Form: Tablet ; Frequency of administration: Orally QD.
Placebo
DrugDosage Form: Tablet; Frequency of administration: Orally QD.
The rate of treatment-emergent adverse events (TEAEs) in each group.
To evaluate the safety and tolerability of ISM5411.
The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
To evaluate the safety and tolerability of ISM5411.
Changes and comparisons of the following data for each group of subjects: vital signs, physical examination, laboratory test(blood routine, blood chemistry, urinalysis, coagulation function, etc.), ECG(Heart rate, RR, PR, QRS,QT, QTcF ), etc.
To evaluate the safety and tolerability of ISM5411.
Peak plasma concentration (Cmax)
To evaluate pharmacokinetics (PK) of ISM5411 in moderately to severely active UC patients.
Peak plasma time (Tmax)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
The total number and proportion of subjects who achieve clinical remission.
To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.
The total number and proportion of subjects who achieve clinical response.
To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.
The total number and proportion of subjects who achieve symptomatic remission.
To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.
Change from baseline (CFB) in modified Mayo Score and Mayo subscore (including rectal bleeding score [RBS], stool frequency score [SFS] and Mayo endoscopic score [MES]) .
To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.
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