A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
详细描述
A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 65 years (inclusive) at Screening.
- •Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)
排除标准
- •Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
- •History of a condition associated with significant immunosuppression, or chronic administration (> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).
研究组 & 干预措施
LIV001
LIV001 will be given orally and daily from baseline until end of study
干预措施: LIV001 (Drug)
Placebo
Placebo will be given orally and daily from baseline until end of study
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities
时间窗: Baseline through Study Completion (Week 12).
Number of subjects with changes in the 12-lead electrocardiogram (ECG)
时间窗: Baseline through Study Completion (Week 12).
次要结局
未报告次要终点