A Study of MEDI7352 in Painful Osteoarthritis of the Knee
- Conditions
- Chronic Pain
- Registration Number
- NCT02508155
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352 At screening and at follow up visit. MRI
- Secondary Outcome Measures
Name Time Method 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 Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC 0-inf; AUC 0-t).
Maximum observed plasma drug concentration (Cmax) of MEDI7352 All visits from screening up to 56 days post single dose/84 days post multiple dose Maximum observed plasma drug concentration (Cmax).
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 Time to maximum observed plasma drug concentration (Tmax).
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 Terminal plasma elimination half-life (t1/2).
Apparent clearance (CL/F). All visits from screening up to 56 days post single dose/84 days post multiple dose Apparent clearance (CL/F).
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 The incidence of anti-drug antibodies (a measure of the body's immune response to the drug).
Pain Numerical Rating Scale (NRS) All visits from screening up to 56 days post single dose/84 days post multiple dose Numerical Rating Scale (NRS)
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.
Patients' Global Impression of Change Scale (PGIC) All visits from screening up to 56 days post single dose/84 days post multiple dose Patients' Global Impression of Change Scale (PGIC)
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom
Research Site🇬🇧Manchester, United Kingdom