First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 45

Inclusion Criteria

1. Male or female aged =18 years and =75 years,
2. Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of UC at least 3 months prior to Screening (a biopsy report supporting the histologic diagnosis must be available),
3. Confirmed diagnosis of mild to moderate UC at Screening as defined by an MMS =4 but <8 and MES of 2 or 3(central reading).
4. Left-sided colitis lesions =10 cm,
5. Subject should be receiving a stable dosing (topical or systemic) regimen of 5-ASA (eg, Asacol, Pentasa, Lialda, Apriso, Delzicol) =4 weeks prior to randomization and continue on that same regimen during the study,
6. Females of childbearing potential (FOCBP) must agree to utilize an acceptable effective or highly effective contraceptive method of birth control, eg, use a male or female condom with or without spermicide or any prescription hormonal contraceptive, during study participation at a minimum and
7. Subject should provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Diagnosis of Crohn’s Disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon,
2. Evidence of a clinically significant, active infection of the gastrointestinal tract (eg, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Vibrio, Aeromonas, Plesiomonas, Cryptosporidium, and toxigenic Clostridium difficile) or of any other organ system at Screening, unless deemed benign (eg, mild common cold),
3. Ulcerative proctitis involving only the rectum,
4. Severe UC as per modified Truelove Witts’ criteria or patients in whom colitis is most severe in the transverse colon or ascending colon,
5. Total colectomy, stoma or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon,
6. Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC,
7. History of colon carcinoma or high-grade dysplasia or absence of total endoscopy =18 months in a subject suffering from UC =8 years,
8. Previous use of any anti-TNF (eg, Infliximab), anti-integrin antibodies (eg, Entyvio) or Janus kinase inhibitors (eg, tofacitinib),
9. Use of sulfasalazine =4 weeks prior to randomization into the study,
10. Use of corticosteroids or any disease-modifying antirheumatic drug (DMARD), including thiopurines (eg, Imuran) =6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (=8 mg methylprednisolone/day or equivalent) for at least 2 weeks prior to colonoscopy and remaining on the same dose up to Visit 8/EDV,
11. Conditions linked to severe immunosuppression (eg, human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy),
12. Leukopenia (total white blood cell count <3500/µL) and/or neutropenia (absolute neutrophil count <1500/µL),
13. Severe anemia (hemoglobin <10 g/dL),
14. Thrombocytopenia (peripheral blood platelet count <100 × 109/L), or any coagulation disorder with significantly increased risk of bleeding,
15. Ongoing or recent (<3 months), significant renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate significantly outside normal limits for age and sex,
16. Ongoing or recent (<3 months), significant hepatic disease as manifested by medical history and/or clinical examination and/or an increase in 2.5 × the upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transpeptidase, or alkaline phosphatase,
17. Clinically significant bone marrow disease if progressive or not controlled,
18. Any protein-losing enteropathy (any cause),
19. Any systemic (autoimmune) disease if progressive or not controlled (uncomplicated and well-controlled diabetes mellitus is allowed),
20. Any granulomatous disease,
21. Increased risk of developing infectious endocarditis including:
- Prosthetic cardiac valves including transcatheter-implanted prostheses and homografts,
- Prosthetic material used for cardiac valve repair such as annuloplasty rings and chords,
- Previous infectious endocarditis, and
- Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device
22. Any history of solid organ or bone marrow transplantation,
23. Use of antibiotics (except for local use), prebiotics, or probi

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): • Incidence of treatment-emergent adverse events.(TEAEs).;Timepoint(s) of evaluation of this end point: Week 2, week 4, week 8, week 10, week 12, week 16 and Phone calls: Day 3, Day7(8) and week 19;Main Objective: • To evaluate the safety and tolerability of MH002 in subjects with mild to moderate ulcerative colitis (UC) ;Secondary Objective: • To evaluate the effect on disease activity of MH002 in UC <br>• To evaluate the mechanistic effects of MH002 in UC <br>

Secondary Outcome Measures

Name	Time	Method

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