NCT00871598已完成1 期
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Plaque Psoriasis - a Double-blind Randomized Placebo-controlled Sequential Group Trial
Biotie Therapies Corp.2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Plasma concentrations of BTT1023
研究概览
简要总结
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index
排除标准
- •Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
- •Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
- •An absolute indication for a known effective treatment
研究组 & 干预措施
Repeat 2.0
Experimental
干预措施: BTT1023 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Single 0.3
Experimental
干预措施: BTT1023 (Drug)
Repeat 1.0
Experimental
干预措施: BTT1023 (Drug)
Repeat 4.0
Experimental
干预措施: BTT1023 (Drug)
Repeat 8.0
Experimental
干预措施: BTT1023 (Drug)
结局指标
主要结局
Plasma concentrations of BTT1023
时间窗: 12 weeks
Adverse events
时间窗: 12 weeks
次要结局
- Change in Psoriasis Area and Severity Index (PASI)(12 weeks)
研究者
研究点 (2)
Loading locations...
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