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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.
An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI7352 IV | Experimental | Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses. |
|
| IV Placebo | Placebo Comparator | Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses. |
|
| MEDI7352 Subcutaneous Injection | Experimental | 1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort. |
|
| Subcutaneous Placebo | Placebo Comparator | 1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI7352 for IV infusion | Biological | MEDI7352 for IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration versus time curves for MEDI7352 | Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC 0-inf; AUC 0-t). | All visits from screening up to 56 days post single dose/84 days post multiple dose |
| Maximum observed plasma drug concentration (Cmax) of MEDI7352 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bell, MB BCh BAO MRCGP FFPM | Biokinetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 10117 | Germany | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
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.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo for IV infusion |
| Biological |
IV Placebo infusion |
|
| MEDI7352 for Subcutaneous Injection | Biological | MEDI7352 for subcutaneous injection |
|
| Placebo for Subcutaneous Injection | Biological | Subcutaneous Placebo Injection |
|
Maximum observed plasma drug concentration (Cmax). |
| 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 | Time to maximum observed plasma drug concentration (Tmax). | 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 | Terminal plasma elimination half-life (t1/2). | All visits from screening up to 56 days post single dose/84 days post multiple dose |
| Apparent clearance (CL/F). | Apparent clearance (CL/F). | All visits from screening up to 56 days post single dose/84 days post multiple dose |
| The presence of anti-drug antibodies (ADAs) to MEDI7352 | The incidence of anti-drug antibodies (a measure of the body's immune response to the drug). | All visits from screening up to 56 days post single dose/84 days post multiple dose |
| Pain Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) | 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. | 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 |
| Patients' Global Impression of Change Scale (PGIC) | Patients' Global Impression of Change Scale (PGIC) | All visits from screening up to 56 days post single dose/84 days post multiple dose |
| Göteborg |
| 413 45 |
| Sweden |
| Research Site | Stockholm | 141 86 | Sweden |
| Research Site | Belfast | BT2 7BA | United Kingdom |
| Research Site | London | NW10 7EW | United Kingdom |
| Research Site | Manchester | M13 9NQ | United Kingdom |
| D007263 |
| Infusions, Parenteral |
| D007267 | Injections |