A Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Eisai Inc.
- 主要终点
- Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of the short-term safety and tolerability of E6011
研究概览
简要总结
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized to one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
100 mg subcutaneous once every 2 weeks with initial double dose (200 mg total)
干预措施: E6011 (Drug)
Cohort 2
200 mg subcutaneous once every 2 weeks with initial double dose (400 mg total)
干预措施: E6011 (Drug)
Cohort 3
400 mg subcutaneous once every 2 weeks with initial double dose (800 mg total)
干预措施: E6011 (Drug)
Cohort 4
10 mg/kg IV at Day 1, Day 8, Day 15, and every 2 weeks thereafter
干预措施: E6011 (Drug)
Placebo
Placebo 2-mL vial solution for injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of the short-term safety and tolerability of E6011
时间窗: Up to 3 years
The short-term safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of E6011 compared to placebo in subjects with active CD. Safety assessments will consist of monitoring and recording all AEs and SAEs; regulatory monitoring of hematology, blood chemistry, and urine values; periodic measurement vital signs and ECGs; and performance of physical examinations.
次要结局
- The number of screen positives, confirm positives, and relative anti-E6011 levels measured in blood samples from participants.(Up to 3 years)
- Change from baseline in the percentage of immunohistochemical staining for the CX3CR1+ protein in intestinal tissue over time.(Up to 3 years)
- Concentration of E6011 measured over time in blood samples.(Up to 3 years)
- The number and percentage of participants with anti-E6011 antibodies detected in blood samples over time.(Up to 3 years)