A Study of MEDI7352 in Painful Osteoarthritis of the Knee

NCT02508155 | Completed Phase 1

• 1 other identifier: D5680C00001
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 6

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

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

  Adverse events, serious adverse events,

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

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

  Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

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

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

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

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

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

  Vital signs (systolic and diastolic BP), heart rate

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

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

  MRI

  At screening and at follow up visit.

Secondary Outcomes (9)

• 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

• Maximum observed plasma drug concentration (Cmax) 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) 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) of MEDI7352

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

• Apparent clearance (CL/F).

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

Study Arms (4)

MEDI7352 IV

EXPERIMENTAL

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

Biological: MEDI7352 for IV infusion

IV Placebo

PLACEBO COMPARATOR

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

Biological: Placebo for IV infusion

MEDI7352 Subcutaneous Injection

EXPERIMENTAL

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

Biological: MEDI7352 for Subcutaneous Injection

Subcutaneous Placebo

PLACEBO COMPARATOR

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

Biological: Placebo for Subcutaneous Injection

Interventions

MEDI7352 for IV infusion BIOLOGICAL

MEDI7352 for IV infusion

MEDI7352 IV

Placebo for IV infusion BIOLOGICAL

IV Placebo infusion

IV Placebo

MEDI7352 for Subcutaneous Injection BIOLOGICAL

MEDI7352 for subcutaneous injection

MEDI7352 Subcutaneous Injection

Placebo for Subcutaneous Injection BIOLOGICAL

Subcutaneous Placebo Injection

Subcutaneous Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Berlin, 10117, Germany

Location

Research Site

Göteborg, 413 45, Sweden

Location

Research Site

Stockholm, 141 86, Sweden

Location

Research Site

Belfast, BT2 7BA, United Kingdom

Location

Research Site

London, NW10 7EW, United Kingdom

Location

Research Site

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Infusions, Intravenous; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Injections

Study Officials

• David Bell, MB BCh BAO MRCGP FFPM

  Biokinetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 24, 2015
• Study Start: November 17, 2015
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

GB (3); SE (2); DE (1)