NCT00868660已完成1 期
A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission
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
- 66
- 试验地点
- 1
- 主要终点
- safety and tolerability
研究概览
简要总结
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
详细描述
A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult male and/or females, 18 to 50 years of age
- •Body mass index (BMI)18-
- •Chrons Inclusion
- •Adult male and/or females, 18 to 60 years of age (inclusive).
- •Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
- •Crohn's Disease Activity Index (CDAI) score <
- •In a stable state of Crohn's disease as per the Investigator's opinion.
- •Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.
排除标准
- •History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
- •Fistula within the 3 months prior to dosing.
- •Ostomy (having ostomy now or at any time in the past).
- •Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day
- •Short Bowel Syndrome (SBS).
- •Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
研究组 & 干预措施
ZP1848
Experimental
Healthy Subjects or Crohn's Disease patients
干预措施: ZP1848 (Drug)
Placebo
Placebo Comparator
Healthy subjects or Crohn's Disease patients
干预措施: ZP1848 (Drug)
结局指标
主要结局
safety and tolerability
时间窗: January2009-January2010
次要结局
- Pharmacokinetics(Jan 2009 - Jan 2010)
研究者
研究点 (1)
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