A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

Inclusion Criteria:

1. Male and female patients aged 18 to 75 years, both inclusive.

2. Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening. Thediagnosis of UC must be confirmed by endoscopic and histologic evidence.

3. Mild to Moderate active disease defined as total score of at least 4 on the mMS,endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least 1.

4. Demonstrated an inadequate response to, loss of response to, or intolerance to anyof the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine,balsalazide)

○ Signs and symptoms of persistently active disease, in the opinion of theinvestigator, during a current or prior course of at least 4 weeks of treatment with 2.4 g/day mesalamine, 4 g/day sulfasalazine, 1 g/day olsalazine, or 6.75 g/daybalsalazide.

5. Have undergone colonoscopy within the past 2 years for extent of disease, and if theUC has been present for > 10 years, have had a colonoscopy with biopsy to rule outdysplasia

6. Patients who meet following laboratory values (assessed within 28 days prior torandomization):

7. WBCs ≥2000/μL

8. Neutrophils ≥1500/μL

9. Platelets ≥100 X 10³/μL

10. Hemoglobin ≥8.5 g/dL

11. Serum creatinine of ≤1.5 X ULN or creatinine clearance >40 mL/minute (usingCockcroft/Gault formula)

12. AST & ALT ≤1.5 X ULN

13. Total bilirubin ≤ 1.5 X ULN

14. Men and women of childbearing potential must agree to use adequate birth controlmeasures during the study. Acceptable methods of birth control in this studyinclude: surgical sterilization, intrauterine device, oral contraceptive,contraceptive patch, long acting injectable contraceptive, partner's vasectomy,double-barrier method (condom or diaphragm with spermicide) or abstinence for atleast 4 weeks prior to study drug administration, during study participation and for 30 days after their last dose of study drug.

15. All patients aged 45 years or over must have had a colonoscopy to screen foradenomatous polyps within 5 years of screening or must have had a colonoscopy atscreening to assess for polyps.

16. Ability to provide written informed consent and to be compliant with the schedule ofprotocol assessments. In case of illiterate patients, thumb impression of thepatients will be obtained along with the signature of the impartial witness orlegally authorized representative (LAR) on the consent form prior to patient'sparticipation in the trial.

Exclusion Criteria:

1. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history ofa fistula consistent with Crohn's disease.

2. Have severe extensive colitis as evidenced by at least one of the following:

3. Physician judgment that the patient is likely to require colectomy or ileostomywithin 12 weeks of baseline.

4. Current evidence of fulminant colitis, toxic megacolon or bowel perforation.

5. Previous total colectomy

6. Have 4 or more of the following i.e Body temperature > 38 C,HR > 110 (bpm),Focal severe or rebound abdominal tenderness,Anemia (hemoglobin [Hgb] < 8.5 g/dL), Transverse colon diameter > 5 cm on plain X-ray.

7. Have positive stool culture for pathogens (O P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated andretested.

8. Patients who have an evidence of pathogenic bowel infection.

9. History of recurrent or chronic infection (e.g. hepatitis B or C, syphilis, TB).

10. Laboratory test positive for HBsAg, HCV or HIV at screening.

11. Have had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolatemofetil (MMF) within 16 weeks of screening.

12. History or planned concurrent treatment with biological agents (infliximab,adalimumab, vedolizumab, and ustekinumab), immunosuppressive agents (e.g.,azathioprine, 6-MP, or methotrexate) or with lymphocyte-depleting therapies (e.g.,Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide,mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab,daclizumab), Janus kinase (JAK) inhibitor (e.g.,Tofacitininb), steroids (e.g.,prednisolone) prior to randomization.

13. History of treatment with an investigational agent within 5 half-lives of that agentprior to randomization.

14. History of treatment with topical rectal 5-ASA or steroids within 2 weeks ofscreening.

15. Receipt of a live vaccine within 4 weeks prior to randomization.

16. Chronic use of therapies that strongly inhibit or induce CYP3A4 metabolism within 4weeks prior to randomization.

17. Clinically relevant cardiovascular, hepatic, neurological, pulmonary,ophthalmological, endocrine, psychiatric or other major systemic disease makingimplementation of the protocol or interpretation of the study difficult or thatwould put the patient at risk by participating in the study.

18. Pregnant or lactating women or women of child bearing potential who have positiveserum beta HCG test at screening.

19. History of significant alcoholism or drug abuse within the past 1 year. History orpresence of significant smoking (more than 10 cigarettes per day) or consumption oftobacco/nicotine products (more than 10 times per day).

20. History of difficulty with donating blood

21. Participants who have participated in any drug research study other than the presenttrial within past 3 months

22. Patients that have undergone significant trauma or major surgery within 4 weeks ofscreening visit.