AZ D5680C00001 - Ph1 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
Duration of Study in the UK
1 years, 3 months, 23 days
Osteoarthritis (OA) is a progressive degenerative joint disease affecting cartilage and subchondral bone and is a common cause of chronic pain. As OA progresses, the affected joints appear larger, stiff and painful, and usually feel better with gentle use but worse with excessive or prolonged use.
Non-steroidal anti-inflammatory drugs (NSAIDs) and opioids provide accessible relief from mild to moderate chronic pain, however both classes are limited by safety concerns, including gastrointestinal bleeds with NSAIDs, and constipation, respiratory depression, and dependence with opioids.
MEDI7352 is being developed for the treatment of chronic pain in OA. It a bi-specific fusion protein that binds nerve growth factor (NGF) to tumour necrosis factor (TNF) receptor 2 (TNFR2). Elevated levels of NGF have been shown in several painful conditions, whilst blocking the TNF receptor has been shown to reduce pain in inflammatory joint diseases in clinical trials.
This study is a randomised, double-blind, placebo-controlled, interleaved single- and multiple ascending dose study in participants aged 18 to 80 with painful OA of the knee. This is the first study of MEDI7352 in humans with the main aims being to assess the safety and tolerability of MEDI7352 versus placebo in participants with painful OA of the knee.
This study is conducted in two parts, the first will involve participants taking a single dose of MEDI7352 (or placebo) and the second part participants taking 4 doses (or placebo), with two weeks between each dose. Up to 53 participants are planned to complete the first part in 7 groups, and up to 90 participants to complete the second part in 5 groups at 7 research sites. Doses will be given intravenously or via injection.
As part of this study, participants will undergo, physical and neurological assessments, as well as blood and urine sampling for laboratory analysis, ECG, X-ray and MRI.
South Central - Oxford A Research Ethics Committee
Date of REC Opinion
14 Sep 2015
Further Information Favourable Opinion