Clinical trial NCT02508155: A Study of MEDI7352 in Painful Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
timeFrame: At screening and at follow up visit.
Secondary outcomes:
measure: Area under the plasma drug concentration versus time curves for MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Maximum observed plasma drug concentration (Cmax) of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Time to maximum observed plasma drug concentration (Tmax) of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Terminal plasma elimination half-life (t1/2) of MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Apparent clearance (CL/F).
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: The presence of anti-drug antibodies (ADAs) to MEDI7352
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Pain Numerical Rating Scale (NRS)
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
measure: Patients' Global Impression of Change Scale (PGIC)
timeFrame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biokinetics
name: David Bell, MB BCh BAO MRCGP FFPM
role: PRINCIPAL_INVESTIGATOR
References: