NCT02985593已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent to participate in the study;
- •Japanese or White men ≥20 and <45 years at the time of informed consent;
排除标准
- •Current illness requiring treatment;
- •Current respiratory, gastric, renal, or liver disease;
- •Inclusion Criteria:
- •Voluntary written informed consent to participate in the study;
- •Men or women ≥20 years of age at the time of informed consent;
- •Ulcerative colitis diagnosed ≥6 months prior to informed consent;
- •Moderate or more severe ulcerative colitis;
- •Exclusion Criteria:
- •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;
- •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);
- •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);
- •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;
- •Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);
- •Any planned surgical treatment during the study;
- •Clostridium difficile infection within 8 weeks prior to enrollment;
- •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;
- •Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment;
- •Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;
研究组 & 干预措施
KHK4083
Experimental
IV/SC administration
干预措施: KHK4083 (Drug)
Placebo
Placebo Comparator
IV/SC administration
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
时间窗: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
次要结局
- Area under the curve (AUC) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
- Time to reach Cmax (tmax) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
- Serum KHK4083 concentration(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
- Maximum concentration (Cmax) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
- Anti-KHK4083 antibody production(art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
研究者
相似试验
已完成
1 期
A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy VolunteersObesityNCT00509132Genaera Corporation42
已完成
1 期
A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic VolunteersDiabetes MellitusObesityNCT00606112Genaera Corporation28
已完成
1 期
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1Myotonic Dystrophy 1NCT06204809PepGen Inc24
已完成
1 期
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian ParticipantsHealthy VolunteersNCT04571424Biogen33
已完成
1 期
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult HumansHealthyNCT04506645Regeneron Pharmaceuticals90