A Study of MEDI7352 in Painful Osteoarthritis of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-17

Study Completion Date

2020-12-23

Brief Summary

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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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Detailed Description

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

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MEDI7352 IV

Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.

Group Type EXPERIMENTAL

MEDI7352 for IV infusion

Intervention Type BIOLOGICAL

MEDI7352 for IV infusion

IV Placebo

Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.

Group Type PLACEBO_COMPARATOR

Placebo for IV infusion

Intervention Type BIOLOGICAL

IV Placebo infusion

MEDI7352 Subcutaneous Injection

1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.

Group Type EXPERIMENTAL

MEDI7352 for Subcutaneous Injection

Intervention Type BIOLOGICAL

MEDI7352 for subcutaneous injection

Subcutaneous Placebo

1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.

Group Type PLACEBO_COMPARATOR

Placebo for Subcutaneous Injection

Intervention Type BIOLOGICAL

Subcutaneous Placebo Injection

Interventions

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MEDI7352 for IV infusion

Intervention Type BIOLOGICAL

Placebo for IV infusion

IV Placebo infusion

Intervention Type BIOLOGICAL

MEDI7352 for Subcutaneous Injection

MEDI7352 for subcutaneous injection

Intervention Type BIOLOGICAL

Placebo for Subcutaneous Injection

Subcutaneous Placebo Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No