NCT03705117已完成1 期
An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Reduction of phosphorylation in mucosal biopsies
研究概览
简要总结
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.
详细描述
Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of UC for 12 months or more
- •Distal disease, accessible by flexible sigmoidoscopy
- •Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1
排除标准
- •A known hypersensitivity to any of the inactive ingredients of the study treatment
- •A diagnosis of any IBD except UC
- •Isolated proctitis
- •Stool culture positive for C. difficile or other enteric infection
- •Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
- •Evidence of previous or present hepatitis B or C infection
- •Known severe viral infection within six weeks prior to Visit 1
- •Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week)
- •Anti-TNFα therapy other than the study drug
- •Parenteral or enteral nutrition therapy
- •Current use of any biologic agent
- •Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor
- •Contraindication to TNFα inhibitor
- •Clinically significant abnormal laboratory test result at screening
- •Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
研究组 & 干预措施
V565
Experimental
V565 orally three times daily for up to 7 days
干预措施: V565 (Biological)
结局指标
主要结局
Reduction of phosphorylation in mucosal biopsies
时间窗: After 7 days oral treatment
Presence of drug in mucosal biopsies
时间窗: After 7 days oral treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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