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.
An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
132
MEDI7352 for IV infusion
IV Placebo infusion
MEDI7352 for subcutaneous injection
Research Site
Berlin, Germany
Research Site
Göteborg, Sweden
Research Site
Stockholm, Sweden
Research Site
Belfast, United Kingdom
Research Site
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Adverse events, serious adverse events,
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
12 Lead electrocardiogram (including QTc, QRS, PR intervals and ventricular rate)
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Vital signs (systolic and diastolic BP), heart rate
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
MRI
Time frame: At screening and at follow up visit.
Area under the plasma drug concentration versus time curves for MEDI7352
Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC 0-inf; AUC 0-t).
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
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Subcutaneous Placebo Injection
London, United Kingdom
Research Site
Manchester, United Kingdom
Maximum observed plasma drug concentration (Cmax) of MEDI7352
Maximum observed plasma drug concentration (Cmax).
Time frame: 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
Time to maximum observed plasma drug concentration (Tmax).
Time frame: 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
Terminal plasma elimination half-life (t1/2).
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Apparent clearance (CL/F).
Apparent clearance (CL/F).
Time frame: 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
The incidence of anti-drug antibodies (a measure of the body's immune response to the drug).
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Pain Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS)
Time frame: 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Patients' Global Impression of Change Scale (PGIC)
Patients' Global Impression of Change Scale (PGIC)
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose