A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis

"Part1: Inclusion Criteria: 1. Voluntary written informed consent to participate in the study; 2. Japanese or White men ≥20 and \<45 years at the time of informed consent; Exclusion Criteria: 1. Current illness requiring treatment; 2. Current respiratory, gastric, renal, or liver disease; Part2: Inclusion Criteria: 1. Voluntary written informed consent to participate in the study; 2. Men or women ≥20 years of age at the time of informed consent; 3. Ulcerative colitis diagnosed ≥6 months prior to informed consent; 4. Moderate or more severe ulcerative colitis; Exclusion Criteria: 1. Definitive diagnosis of bacillary dysentery, amebic colitis, Salmonella enteritis, Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis, Crohn's disease, radiation colitis, drug-induced colitis, angiolymphoid hyperplasia, ischemic colitis, or intestinal Behcet's disease; 2. Any of the following clinically significant concurrent illnesses: * Type 1 diabetes * Poorly controlled type 2 diabetes (HbA1c \>8.5%) * Congestive heart failure (class II to IV of the New York Heart Association classification) * Myocardial infarction within 1 year * Unstable angina pectoris within 1 year * Poorly controlled hypertension (systolic pressure \>150 mmHg or diastolic pressure \>90 mmHg at screening) * Severe chronic lung diseases requiring oxygen therapy * Multiple sclerosis or other demyelinating diseases * Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma); 3. Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 2); 4. Suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data within 1 year prior to enrollment; suspected or confirmed toxic megacolon or history of toxic megacolon; history of any colonic resection, subtotal or total colectomy, ileostomy, or colostomy; or any previous surgery for ulcerative colitis or an anticipated requirement for surgery for ulcerative colitis; 5. Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis); 6. Any planned surgical treatment during the study; 7. Clostridium difficile infection within 8 weeks prior to enrollment; 8. Any active infection, including Grade ≥2 localized diseases per Common Terminology Criteria for Adverse Events, version 4.0, Japan Clinical Oncology Group edition (CTCAE v4.0-JCOG), within 4 weeks prior to enrollment; 9. Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment; 10. Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;