NCT01258205已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease
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
- AstraZeneca
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A - Healthy Subjects:
- •Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
- •Body mass index (BMI) between 18 and 32 kg/m2
- •Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
- •Additional inclusion criteria apply
- •Part B - Crohn's Subjects:
- •Male or female subjects with CD between 18 to 55 years-of-age
- •Body mass index (BMI) between 18 and 32 kg/m2
- •Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
- •Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
- •Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
- •Elevated fecal calprotectin and CRP
- •Additional inclusion criteria apply
排除标准
- •Parts A - Healthy Subjects:
- •History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- •Recent or on-going infection(s)
- •Underlying condition(s) that predisposes the subject to infections
- •History of malignancy of any type
- •Additional exclusion criteria apply
- •Part B only - Crohn's Subjects:
- •History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- •Recent or on-going infection(s)
- •Underlying condition(s) that predisposes the subject to infections
- •History of malignancy of any type
- •Additional exclusion criteria apply
研究组 & 干预措施
Part B
Experimental
One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
干预措施: AMG 139 (Drug)
Part A
Experimental
Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.
干预措施: AMG 139 (Drug)
结局指标
主要结局
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
时间窗: 36 weeks
次要结局
- Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD(36 weeks)
研究者
研究点 (7)
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