NCT00694980已完成1 期
A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients 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
- 48
- 主要终点
- Incidence, nature, and severity of adverse events
研究概览
简要总结
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent
- •18-70 years of age
- •Males and females with reproductive potential: Willing to use a reliable method of contraception
- •Diagnosis of ulcerative colitis
- •Eligible to receive biologic therapy
- •Disease duration of >=12 weeks
排除标准
- •Requirement for hospitalization due to severity of ulcerative colitis
- •Moderate to severe anemia
- •Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study
- •Pregnant or lactating
- •Lack of peripheral venous access
- •Inability to comply with study protocol
- •History or presence of contraindicated diseases
- •Congenital immune deficiency
- •Active or prior infection with HIV or hepatitis B or C
- •History of severe systemic bacterial, fungal, viral, or parasitic infections
- •History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
- •Received a live attenuated vaccine within 4 weeks prior to screening
- •Hospitalized within 4 weeks prior to screening
- •Received any contraindicated therapy within 12 weeks prior to screening
研究组 & 干预措施
1
Experimental
干预措施: placebo (Drug)
1
Experimental
干预措施: rhuMAb Beta7 (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events
时间窗: Through study completion or early study discontinuation
Incidence and nature of laboratory abnormalities
时间窗: Through study completion or early study discontinuation
次要结局
- Incidence of antibodies directed against rhuMAb Beta7(Through study completion or early study discontinuation)
- PK profile and parameters(Through study completion or early study discontinuation)
研究者
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