A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Change in clinical lab test results
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
详细描述
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of Rheumatoid Arthritis (RA) > 3 months.
- •On methotrexate (MTX) therapy => 3 months and on a stable dose for at least 4 weeks.
- •Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
- •Body Mass Index (BMI) is 19 to 38, inclusive.
- •Other than RA, subjects should be in good general health.
排除标准
- •Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
- •History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
- •History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
- •History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
- •Subject has any medical condition or illness other than RA that is not well controlled with treatment.
研究组 & 干预措施
Group 1
Randomized 6 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 2
Randomized 6 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 3
Randomized 6 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 1
Randomized 6 drug/2 placebo by group
干预措施: ABT-122 (Biological)
Group 2
Randomized 6 drug/2 placebo by group
干预措施: ABT-122 (Biological)
Group 3
Randomized 6 drug/2 placebo by group
干预措施: ABT-122 (Biological)
结局指标
主要结局
Change in clinical lab test results
时间窗: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Hematology, Chemistry, and Urinalysis
Change in Electrocardiogram (ECG) results
时间窗: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
ECGs done in triplicate
Determination of pharmacokinetic (PK) parameters
时间窗: Prior to first dose up to 42 days after the last dose of ABT-122
Cmax, Tmax, AUC, elimination rate constant and half-life
Number of participants with Adverse Events
时间窗: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Collect all adverse events at each visit
Change in physical exam including vital signs
时间窗: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Blood pressure, pulse and body temperature
次要结局
- Measurement of anti-drug anti-bodies (ADA) of ABT-122(Prior to each dose and up until 42 days after the last dose of ABT-122)