A Study of MEDI7352 in Painful Osteoarthritis of the Knee

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02508155

Enrollment

132

Registered

2015-07-24

Start date

2015-11-17

Completion date

2020-12-23

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

BIOLOGICALMEDI7352 for IV infusion

MEDI7352 for IV infusion

BIOLOGICALPlacebo for IV infusion

IV Placebo infusion

BIOLOGICALMEDI7352 for Subcutaneous Injection

MEDI7352 for subcutaneous injection

BIOLOGICALPlacebo for Subcutaneous Injection

Subcutaneous Placebo Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	All visits from screening up to 56 days post single dose/84 days post multiple dose	Adverse events, serious adverse events,

Secondary

Measure	Time frame	Description
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).
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).
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)
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).

Countries

Germany, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026