A Study of MEDI7352 in Painful Osteoarthritis of the Knee

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.