A Randomized, Double-Blind, Placebo Controlled Study in Patients With Osteoarthritis of the Knee to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of ABT-981
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Physical Exam including vital signs
研究概览
简要总结
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
详细描述
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female, 40 to 70 years of age, inclusive.
- •History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
- •Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
- •Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
- •Other than Osteoarthritis (OA) of the study joint, patient should be in general good health
排除标准
- •Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
- •History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
- •Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
- •Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
- •Any uncontrolled medical illness including unstable treatment or therapy.
研究组 & 干预措施
Group 4
Randomized 7 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 1
Randomized 7 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 2
Randomized 7 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 3
Randomized 7 drug/2 placebo by group
干预措施: Placebo (Biological)
Group 4
Randomized 7 drug/2 placebo by group
干预措施: ABT-981 (Biological)
Group 1
Randomized 7 drug/2 placebo by group
干预措施: ABT-981 (Biological)
Group 2
Randomized 7 drug/2 placebo by group
干预措施: ABT-981 (Biological)
Group 3
Randomized 7 drug/2 placebo by group
干预措施: ABT-981 (Biological)
结局指标
主要结局
Physical Exam including vital signs
时间窗: From date of first dose of ABT-981 until 70 days after last dose of ABT-981
Blood pressure, heart rate and body temperature
Clinical Lab Testing
时间窗: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Hematology, Chemistry, and Urinalysis
Time to Cmax (Tmax) of ABT-981
时间窗: Prior to first dose up to 70 days after the last dose of ABT-981
Time to Cmax
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
时间窗: Prior to the last dose up to 70 days after the last dose of ABT-981
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
Number of participants with Adverse Events
时间窗: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Collect all adverse events at each visit
Maximum observed serum concentration (Cmax) of ABT-981
时间窗: Prior to first dose up to 70 days after the last dose of ABT-981
Cmax
Change from Baseline in Electrocardiogram (ECG)
时间窗: Prior to dose and 8 hours post dose on each day of dosing
ECGs done in triplicate
The area under the time curve (AUC) of ABT-981
时间窗: Prior to first dose up until 70 days after the last dose of ABT-981
AUC
次要结局
- Measurement of anti-drug anti-bodies (ADA) of ABT-981(Prior to each dose and up until 70 days after the last dose of ABT-981)