NCT01878123已完成1 期
A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
研究概览
简要总结
This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to provide written informed consent
- •Body mass index 18.5 to 35.0 kg/m2
- •Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
- •Global Functional Class I, II, or III according to ACR 1991 revised criteria
- •Stable use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 4 weeks prior to Day 0, including:
- •Methotrexate (MTX) 7.5 - 25 mg/week
- •Hydroxychloroquine (HCQ) </= 400 mg/day
- •Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
- •Leflunomide 5 - 20 mg/day
- •Azathioprine 150 mg/day or 2 mg/kg/day
- •Combinations of MTX, HCQ, and/or SSZ allowed
排除标准
- •Prior to Day 0, use of
- •Rituximab within 6 months
- •Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
- •Etanercept or Anakinra within 28 days
- •Immunoglobulin or blood products within 28 days
- •Evidence of any active or recent infection including ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
- •History of systemic autoimmune disease other than Rheumatoid Arthritis
- •History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
- •History of anaphylaxis or allergic diathesis
- •Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
- •Evidence of active or latent tuberculosis
- •Vaccination wtih live attenuated viruses within the 2 weeks prior to Day 0
- •Evidence of infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1 or 2, or active infection with hepatitis A
- •Pregnant or breastfeeding women
结局指标
主要结局
Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
时间窗: From start of study drug administration through Day 56
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials
时间窗: From start of study drug administration through Day 56
Based on the occurrence of dose-limiting toxicities (through Day 14)
次要结局
- Evaluate pharmacokinetic profile of a single dose of AMP-110(From Day 0 pre-dose through Day 28)
研究者
研究点 (6)
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