Investigate the effects of MEDI-578 in patients with osteoarthritis
Research type
Research Study
Full title
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusion of MEDI-578, an Anti-nerve Growth Factor Monoclonal Antibody, after Single Ascending Doses in Male and Non-fertile Female Patients with Painful Osteoarthritis of the Knee
IRAS ID
27597
Contact name
Darren Wilbraham
Sponsor organisation
AstraZeneca
Eudract number
2009-012995-28
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
Nerve growth factor (NGF) is a naturally occurring chemical which is known to be a mediator of chronic pain in conditions like arthritis, chronic headaches etc. MEDI-578 is a new monoclonal antibody that binds NGF to neutralize its functions. It is being developed for the treatment of pain. The purpose of this study is to investigate how the body handles single doses of MEDI-578 in patients with osteoarthritis (OA) of the knee. Specifically, how the drug is distributed, and broken down by the body, its safety, tolerability and whether MEDI-578 improves OA pain symptoms. During this study subjects will receive a single dose of MEDI-578 intravenously (injection into a vein). A maximum of 56 patients with OA will participate in this study. The study starts with a period when patients will need to stop their current medication, called a washout period. The length of the washout period is dependent on the patient??s current treatment and other prohibited pre-study medications. After a residential stay of 4 days at the Quintiles Drug Research Unit subjects will go home and thereafter visit the unit at seven subsequent visits including the last visit at Day 84.
REC name
London - London Bridge Research Ethics Committee
REC reference
09/H0804/96
Date of REC Opinion
4 Feb 2010
REC opinion
Further Information Favourable Opinion