A Study of MEDI7352 in Painful Osteoarthritis of the Knee

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Biological: Placebo for IV infusion; Biological: Placebo for Subcutaneous Injection; Biological: MEDI7352 for IV infusion; Biological: MEDI7352 for Subcutaneous Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02508155

D5680C00001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 132 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 4 patient groups, including a placebo group

MEDI7352 IV

Experimental group

Description:

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

Treatment:

Biological: MEDI7352 for IV infusion

IV Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo for IV infusion

MEDI7352 Subcutaneous Injection

Experimental group

Description:

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

Treatment:

Biological: MEDI7352 for Subcutaneous Injection

Subcutaneous Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo for Subcutaneous Injection