A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
研究概览
简要总结
The purpose of this study is to assess the safety, drug levels and effects on the body of MEDI7352, in subjects with painful osteoarthritis of the knee.
详细描述
An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with painful osteoarthritis (OA) of the knee. Female subjects must be postmenopausal or surgically sterile.
- •Body weight between 50kg and 145kg
- •Willing and able to comply with the requirements of the protocol
排除标准
- •Current treatment with another biologic therapeutic agent
- •Current of historical diagnosis of RA
- •Current diagnosis of an immunological condition that is associated with another form of arthritis in addition to OA, including traumatic arthritis or a seronegative spondyloarthropathy
- •At risk of destructive arthropathy, including Rapidly Progressive Osteoarthritis (RPOA), osteonecrosis, spontaneous osteonecrosis of the knee, subchondral insufficiency fractures, hip dislocation and pathological fracture
- •Presence of clinically significant neuropathy or other clinically significant disorder involving abnormal peripheral sensation.
- •Current serious or unstable clinically important illness.
研究组 & 干预措施
MEDI7352 IV
Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
干预措施: MEDI7352 for IV infusion (Biological)
IV Placebo
Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
干预措施: Placebo for IV infusion (Biological)
MEDI7352 Subcutaneous Injection
1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
干预措施: MEDI7352 for Subcutaneous Injection (Biological)
Subcutaneous Placebo
1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
干预措施: Placebo for Subcutaneous Injection (Biological)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
时间窗: At screening and at follow up visit.
MRI
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
时间窗: All visits from screening up to 56 days post single dose/84 days post multiple dose
Adverse events, serious adverse events,
次要结局
- Area under the plasma drug concentration versus time curves for MEDI7352(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Maximum observed plasma drug concentration (Cmax) of MEDI7352(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Time to maximum observed plasma drug concentration (Tmax) of MEDI7352(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Terminal plasma elimination half-life (t1/2) of MEDI7352(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Apparent clearance (CL/F).(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- The presence of anti-drug antibodies (ADAs) to MEDI7352(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Pain Numerical Rating Scale (NRS)(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.(All visits from screening up to 56 days post single dose/84 days post multiple dose)
- Patients' Global Impression of Change Scale (PGIC)(All visits from screening up to 56 days post single dose/84 days post multiple dose)