Chronic PainPhase 1NCT02508155
A Study of MEDI7352 in Painful Osteoarthritis of the Knee
A Phase 1 study testing MEDI7352 for IV infusion and MEDI7352 for Subcutaneous Injection in people with Chronic Pain, run by AstraZeneca at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MEDI7352 for IV infusion and MEDI7352 for Subcutaneous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 17 Nov 2015to 23 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom3 sites
Research Site
Belfast, BT2 7BA
Research Site
London, NW10 7EW
Research Site
Manchester, M13 9NQ
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- MEDI7352 for IV infusion, Placebo for IV infusion, MEDI7352 for Subcutaneous Injection, Placebo for Subcutaneous Injection
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7352 for IV infusionBiological
MEDI7352 for IV infusion
Placebo for IV infusionBiological
IV Placebo infusion
MEDI7352 for Subcutaneous InjectionBiological
MEDI7352 for subcutaneous injection
Placebo for Subcutaneous InjectionBiological
Subcutaneous Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| MEDI7352 IV | Experimental | Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Placebo for Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Adverse events, serious adverse events,
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At screening and at follow up visit.
Secondary outcomes (9)
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).
Measured: All visits from screening up to 56 days post single dose/84 days post multiple dose
Maximum observed plasma drug concentration (Cmax) of MEDI7352
Maximum observed plasma drug concentration (Cmax).
Measured: 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).
Measured: 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).
Measured: All visits from screening up to 56 days post single dose/84 days post multiple dose
Apparent clearance (CL/F).
Apparent clearance (CL/F).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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)
Measured: All visits from screening up to 56 days post single dose/84 days post multiple dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start17 Nov 2015
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bell, MB BCh BAO MRCGP FFPM, Principal investigator, Biokinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508155
- Sponsor's protocol ID
- D5680C00001
- Status last verified
- Apr 2021
- First submitted
- 2 Jul 2015
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02508155
- Acronym / sponsor ID
- D5680C00001
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MEDI7352 IV | Experimental | Biological: MEDI7352 for IV infusionUp to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses. |
| IV Placebo | Placebo comparator | Biological: Placebo for IV infusionUp to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses. |
| MEDI7352 Subcutaneous Injection | Experimental | Biological: MEDI7352 for Subcutaneous Injection1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort. |
| Subcutaneous Placebo | Placebo comparator | Biological: Placebo for Subcutaneous Injection1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI7352 for IV infusionMEDI7352 for IV infusion | Biological | MEDI7352 IV |
| Placebo for IV infusionIV Placebo infusion | Biological | IV Placebo |
| MEDI7352 for Subcutaneous InjectionMEDI7352 for subcutaneous injection | Biological | MEDI7352 Subcutaneous Injection |
| Placebo for Subcutaneous InjectionSubcutaneous Placebo Injection | Biological | Subcutaneous Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Adverse events, serious adverse events,
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
12 Lead electrocardiogram (including QTc, QRS, PR intervals and ventricular rate)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Vital signs (systolic and diastolic BP), heart rate
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time frame: At screening and at follow up visit.
MRI
9 secondary outcomes
Area under the plasma drug concentration versus time curves for MEDI7352
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Maximum observed plasma drug concentration (Cmax) of MEDI7352
Time frame: 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 frame: 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
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Apparent clearance (CL/F).
Time frame: 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
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Pain Numerical Rating Scale (NRS)
Time frame: 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.
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Patients' Global Impression of Change Scale (PGIC)
Time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bell, MB BCh BAO MRCGP FFPM principal investigator
Biokinetics
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI7352 for IV infusion and MEDI7352 for Subcutaneous Injection in people with Chronic Pain, run by AstraZeneca at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Sweden, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352 (time frame: All visits from screening up to 56 days post single dose/84 days post multiple dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.