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Completed

NCT Number: NCT02508155

A Study of MEDI7352 in 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Berlin, Germany

Loading trial locations.

About this study

An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDI7352 for IV infusion

Biological

MEDI7352 for IV infusion

Placebo for IV infusion

Biological

IV Placebo infusion

MEDI7352 for Subcutaneous Injection

Biological

MEDI7352 for subcutaneous injection

Placebo for Subcutaneous Injection

Biological

Subcutaneous Placebo Injection

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Adverse events, serious adverse events,

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    12 Lead electrocardiogram (including QTc, QRS, PR intervals and ventricular rate)

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Vital signs (systolic and diastolic BP), heart rate

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352

    Time frame: At screening and at follow up visit.

    MRI

Secondary outcomes

  1. Area under the plasma drug concentration versus time curves for MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC 0-inf; AUC 0-t).

  2. Maximum observed plasma drug concentration (Cmax) of MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Maximum observed plasma drug concentration (Cmax).

  3. Time to maximum observed plasma drug concentration (Tmax) of MEDI7352

    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).

  4. Terminal plasma elimination half-life (t1/2) of MEDI7352

    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).

  5. Apparent clearance (CL/F).

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Apparent clearance (CL/F).

  6. The presence of anti-drug antibodies (ADAs) to MEDI7352

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    The incidence of anti-drug antibodies (a measure of the body's immune response to the drug).

  7. Pain Numerical Rating Scale (NRS)

    Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose

    Numerical Rating Scale (NRS)

  8. 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

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.

  9. 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

    Patients' Global Impression of Change Scale (PGIC)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2015
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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