NCT01094093已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
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
- 73
- 试验地点
- 4
- 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 single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).
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 Volunteers:
- •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 - Psoriasis Subjects:
- •Male or female of non-reproductive potential subjects with PsO 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 moderate to severe plaque PsO
- •Diagnosis of plaque PsO for at least 6 months
- •Moderate to severe plaque PsO defined by:
- •A minimum PASI score of ≥ 10
- •Psoriasis involving ≥ 10% of the Body Surface Area (BSA)
- •Additional inclusion criteria apply
排除标准
- •Parts A - Healthy Volunteers:
- •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, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
- •Additional exclusion criteria apply
- •Part B - Psoriasis 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
- •Guttate, pustular, or other non-plaque forms of PsO
- •Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
- •History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
- •Additional exclusion criteria apply
研究组 & 干预措施
Part B
Experimental
Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B).
干预措施: AMG 139 (Drug)
Part A
Experimental
Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers.
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: 16-24 weeks
次要结局
- Characterization of the pharmacokinetics (PK) of AMG 139(16-24 weeks)
- Psoriasis Activity and Severity Index (PASI) scores (Part B only)(16-24 weeks)
研究者
研究点 (4)
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