Healthy men and subjects with ulcerative colitis
Conditions
Interventions
investigational material(s)
Generic name etc : KHK4083
INN of investigational material :
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investig
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part1: 1) Voluntary written informed consent to participate in the study; 2) Japanese or White men >=20 and =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
Exclusion criteria: Part1: 1) Current illness requiring treatment 2) Current respiratory, gastric, renal, or liver disease Part2: 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 diastric 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 (expept 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 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 enrollement 10) Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile anti-KHK4083 antibody production | — |
Outcome results
None listed