a phase 1 study of khk4083 in healthy volunteers and subjects with ulcerative colitis

Conditions: Healthy Men and Subjects With Ulcerative Colitis

Summary: the objectives of this study are to evaluate the safety and tolerability of a single intravenous (iv) or subcutaneous (sc) dose of khk4083 in japanese or white healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple iv doses of khk4083 in subjects with ulcerative colitis in an open-label study.


Eligibility criteria:
"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;