A Study of MEDI7352 in Painful Osteoarthritis of the Knee

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Biological: MEDI7352 for IV infusion; Biological: MEDI7352 for Subcutaneous Injection; Biological: Placebo for IV infusion; Biological: Placebo for Subcutaneous Injection

• Registration Number: NCT02508155
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Study Start: 2015-11-17
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI7352 IV	MEDI7352 for IV infusion	Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
MEDI7352 Subcutaneous Injection	MEDI7352 for Subcutaneous Injection	1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
IV Placebo	Placebo for IV infusion	Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
Subcutaneous Placebo	Placebo for Subcutaneous Injection	1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	At screening and at follow up visit.	MRI

Secondary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration versus time curves for MEDI7352	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).
Maximum observed plasma drug concentration (Cmax) of MEDI7352	All visits from screening up to 56 days post single dose/84 days post multiple dose	Maximum observed plasma drug concentration (Cmax).
Time to maximum observed plasma drug concentration (Tmax) of MEDI7352	All visits from screening up to 56 days post single dose/84 days post multiple dose	Time to maximum observed plasma drug concentration (Tmax).
Terminal plasma elimination half-life (t1/2) of MEDI7352	All visits from screening up to 56 days post single dose/84 days post multiple dose	Terminal plasma elimination half-life (t1/2).
Apparent clearance (CL/F).	All visits from screening up to 56 days post single dose/84 days post multiple dose	Apparent clearance (CL/F).
The presence of anti-drug antibodies (ADAs) to MEDI7352	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).
Pain Numerical Rating Scale (NRS)	All visits from screening up to 56 days post single dose/84 days post multiple dose	Numerical Rating Scale (NRS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.	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.
Patients' Global Impression of Change Scale (PGIC)	All visits from screening up to 56 days post single dose/84 days post multiple dose	Patients' Global Impression of Change Scale (PGIC)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom