JPRN-jRCT2080223390未知1 期
A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects with Ulcerative Colitis
Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 52 人开始时间: 2016年11月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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;
- •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
排除标准
- •1) Current illness requiring treatment
- •2) Current respiratory, gastric, renal, or liver disease
- •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
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