A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- Safety and toleration
研究概览
简要总结
study to investigate the safety and efficacy properties of PF-00547659 in patients with active 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
- •A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer.
- •Active UC as defined by a score of ≥6 on the Mayo score.
- •An endoscopic (by flexible sigmoidoscopy) sub-score of ≥2 on the Mayo score determined within 7 days of first dosing.
排除标准
- •Subjects with UC, which is confined to a proctitis on a flexible sigmoidoscopy.
- •Subjects who have had surgery as a treatment for UC or are likely to require surgery within the duration of the study.
- •Subjects displaying clinical signs of ischemic colitis.
研究组 & 干预措施
0.3 mg/kg or placebo sc
干预措施: Single dose-group A (Biological)
0.3 mg/kg or placebo sc
干预措施: Multiple dose-Group B (Biological)
0.1 mg/kg or placebo iv (multiple dose)
干预措施: Multiple dose- Group B (Biological)
0.3 mg/kg or placebo iv (multiple dose)
干预措施: Multiple dose- Group B (Biological)
3.0 mg/kg or placebo iv
干预措施: Multiple dose- Group B (Biological)
0.1 mg/kg or placebo sc
干预措施: Multiple dose- Group B (Biological)
0.3 mg/kg or placebo sc (multiple dose)
干预措施: Multiple dose-Group B (Biological)
0.3 mg/kg or placebo iv
干预措施: Multiple dose- Group B (Biological)
1.0 mg/kg or placebo iv
干预措施: Single dose-group A (Biological)
3.0 mg/kg or placebo sc
干预措施: Single dose-group A (Biological)
10 mg/kg or placebo iv
干预措施: Single dose-group A (Biological)
0.03 mg/kg or placebo iv
干预措施: Single dose-group A (Biological)
0.1 mg/kg or placebo iv
干预措施: Single dose-group A (Biological)
0.1 mg/kg or placebo iv
干预措施: Multiple dose- Group B (Biological)
0.3 mg/kg or placebo iv
干预措施: Single dose-group A (Biological)
结局指标
主要结局
Safety and toleration
时间窗: up to 12 weeks
Endoscopic score changes as calculated using section 3 of the Mayo Score
时间窗: up to 12 weeks
Disease activity score changes as calculated using the Mayo Score
时间窗: up to 12 weeks
次要结局
- Plasma concentrations of PF-00547659(up to 12 weeks)
- Fecal concentrations of calprotectin(up to 12 weeks)
- Plasma concentrations of CRP(up to 12 weeks)