Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis

Exclusion Criteria

• •1. Pregnant or breastfeeding women.
• •2. Contraindication to colonoscopy or sigmoidoscopy.
• •3. Allergies to any component of TJ301.
• •4. Subject who is likely to receive surgery for UC treatment within 1 month based on investigator's evaluation.
• •5. History of colostomy, colectomy or partial colectomy.
• •6. Current diagnosis of inflammatory bowel disease unclassified, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon, patients with ulcerative colitis limited to the rectum (ulcerative proctitis), infective enteritis, amebic bowel disease or intestinal schistosomiasis.
• •8. Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count \<1500/μL); or lymphopenia (absolute lymphocyte count \<500/μL).
• •9. Moderate to severe anaemia (haemoglobin \<9 g/dL), or thrombocytopenia (platelet count \<75 000/μL), or serum creatinine \>2 mg/dL.
• •10. Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
• •11. Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to Randomization.
• •12. serum transaminases \>2.5 x upper limit of normal \[ULN\], alkaline phosphatase \>2.5 x ULN.
• •13. Serious underlying disease other than UC in the opinion of the investigator.
• •14. History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
• •15. Any indication of the regular use of more than 40 grams of alcohol every day.
• •16. Smokers who smoke more than 10 cigarettes per day.
• •17. Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
• •18. Presence or history of active tuberculosis (TB) or latent TB infection, defined as 1) a positive QuantiFERON-TB Gold test at Screening; or 2) a T-spot test within 4 weeks of Randomisation and evidence of current or previous pulmonary tuberculosis by low-dose CT or chest X-ray within 12 weeks of Randomisation. Patients with old TB will also be excluded.
• •19. Positive immunoglobulin M antibody titres to Epstein-Barr virus (EBV).
• •20. Subjects with positive results for cytomegalovirus at screening are to be excluded.
• •21. Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to Randomization (whichever is longer).
• •22. Currently taking any medications other than those allowed per protocol guidelines.
• •23. Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or antifungals within 14 days prior to Randomisation.
• •24. Received any live (attenuated) vaccines within 30 days prior to Randomisation.
• •25. Recent treatment with medium-to-high-dose intravenous corticosteroids (methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 8 weeks prior to Randomisation or oral corticosteroids of more than 20 mg prednisone per day (or equivalent).
• •26. Receipt of cyclosporine, tacrolimus, sirolimus, thalidomide, or mycophenolate mofetil within 30 days prior to Randomisation.
• •27. Treatment with therapeutic enema or suppository, other than required for endoscopy preparation, within 14 days prior to the screening endoscopy and during the remainder of the trial.