Painful Osteoarthritis of the KneePhase 1NCT04770428
Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI7352 in Healthy Volunteers
A Phase 1 study testing MEDI7352 in people with Painful Osteoarthritis of the Knee, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of MEDI7352 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Osteoarthritis of the Knee
- What is being tested?
- MEDI7352
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2021to 2 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female of non childbearing potential participants aged 18 to 65 (inclusive) years for Caucasian participants and 20 to 65 (inclusive) years for Japanese participants with suitable veins for cannulation or repeated venepuncture
- Japanese or Caucasian ethnicity
- Post-menopausal women must have had ≥ 12 months of spontaneous amenorrhea with an follicle stimulating hormone (FSH) concentration consistently ≥ 40 mIU/mL and a negative serum or urine pregnancy test result at Screening or Day -1. Surgically sterile women must have had a hysterectomy, and bilateral ovariectomy (oophorectomy), must provide documentation of the procedure and have had a negative serum or urine pregnancy test at Screening or Day -1. An intermediate or positive pregnancy test, can be confirmed by repeating the pregnancy test and demonstrating non-doubling of β-human chorionic gonadotropin levels every 48 to 72 hours
- Men who are biologically capable of fathering children must agree and commit to use of an adequate form of a highly effective method of contraception and refrain from sperm donation for the duration of the Treatment Period and for 3 months after the last administration of study treatment
- Body mass index 18 and 30 kg/m^2, weight at least 50 kg
- No clinically significant abnormality identified on medical or laboratory evaluation at Screening unless the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
- 12-lead electrocardiogram recorded at Screening and Day -1 that is normal for the age group and shows no significant abnormalities that will compromise safety
- Physical examinations with no significant findings at Screening and on Day -1.
Who cannot join
- Participation in another clinical study or use of any experimental medication, device, or biologic with an investigational product (IP) within 5 half-lives of that IP or 3 months (whichever is longer) prior to first dosing
- Participation in another study investigating any form of anti-NGF or anti-TNF therapy in the 6 months prior to Screening and until after the final Follow-up Visit
- Any positive laboratory result at screening for COVID-19
- Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 prior to Screening
- Inability to comply with study-related restrictions and requirements related to consumption of alcohol, provision of meals and snacks, nicotine use, activity, blood donation, and contraception
- History of severe allergy/hypersensitivity reactions or ongoing severe allergy/hypersensitivity reactions, or history of hypersensitivity to immunizations or immunoglobulins or other biological modalities
Show all 19Show fewer
- History of any significant psychiatric disorder
- Any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic, rheumatologic or endocrine disease or disorder
- Recent (within the last 3 months) or active infection considered to be clinically significant, or any infection for which there are unresolved medical sequelae
- Clinically significant osteoarthritis (OA) currently affecting a major joint in the upper or lower extremity or axial spine; or other degenerative disease affecting any joint in participants for whom, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy; or history of trauma or surgery involving any major joint or axial spine
- Radiological significant abnormalities reported on baseline MRI of hips and knees that are considered to present a risk of osteonecrosis, rapidly progressive OA, subchondral insufficiency fractures; or other coincidental finding(s) that present a risk to the safety or welfare of the participant
- History of excessive alcohol intake
- History of cancer within 5 years, with the exception of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix or non-progressive prostate cancer
- History of drug abuse or positive test for drugs of abuse or alcohol
- Use of prescription or non-prescription drugs, including vitamins and herbal and dietary supplements, within 7 days or 5 half-lives of the drug (whichever is longer) prior to the administration of study treatment
- Any clinically important or significant abnormality on a physical examination, vital signs, ECG or clinical laboratory test results that could be detrimental to participant safety or compromise the study
- Positive serologic findings at Screening for Human immunodeficiency virus antibodies, hepatitis B surface antigen or hepatitis C virus antibodies
- Positive QuantiFERON test for tuberculosis
- Any minor medical or surgical procedure or trauma within 28 days of Day 1 or planned surgical procedure during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Doses of MEDI7352 Administered by the Subcutaneous Route in Healthy Japanese and Caucasian Subjects
This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of MEDI7352 in healthy participants.
Read the detailed description
The study will comprise:
- A Screening Period of up to 36 days (approximately 5 weeks);
- A Treatment Period of 6 weeks where participants will be given 1 dose of study treatment every 2 weeks (4 doses in total). Participants will be required to stay in the Clinical Unit from Days -1 to 8 (Visit 2), from Days 14 to 15 (Visit 6), from Days 28 to 29 (Visit 9), and from Days 42 to 50 (Visit 12). In addition, participants will have multiple visits to the Clinical Unit to complete the study assessments;
- A Follow-up Period of 42 days (6 weeks) where participants will also have multiple visits to the Clinical Unit to complete the study assessments, and;
- A final Follow-up Visit after 42 days after the Treatment Period.
Participants will receive fixed multiple subcutaneous (SC) doses of MEDI7352 or placebo on 4 occasions; one dose every 2 weeks on Days 1, 15, 29 and 43, under fasted conditions.
- Conditions
- Painful Osteoarthritis of the Knee
- Being tested
- MEDI7352, Placebo
- Keywords
- MEDI7352, Bi-specific fusion protein, Multiple doses, Subcutaneous route, Pharmacokinetics, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7352Drug
A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.
PlaceboDrug
Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Japanese MEDI7352 | Experimental | Randomized Japanese participants will receive single doses of MEDI7352 subcutaneously. Receives: Drug: MEDI7352 |
| Cohort 1: Japanese Placebo | Placebo comparator | Randomized Japanese participants will receive matching placebo subcutaneously. Receives: Drug: Placebo |
| Cohort 2: Caucasian MEDI7352 | Experimental | Randomized Caucasian participants will receive single doses of MEDI7352 subcutaneously. Receives: Drug: MEDI7352 |
| Cohort 2: Caucasian Placebo | Placebo comparator | Randomized Caucasian participants will receive matching placebo subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of MEDI7352 in healthy Japanese and Caucasian participants following multiple dosing by the SC route
Measured: Upto Final Follow-up (Day 84) or Early Termination
Secondary outcomes (11)
Maximum concentration (Cmax) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to pharmacokinetic (PK) following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Time of Cmax (tmax) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to infinity (AUCinf) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable serum concentration (AUClast) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve for the dosing interval (AUCτ) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Average drug concentration over a dosing interval (Cavg) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent volume of distribution at steady state (Vss/F) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Half-life (t1/2) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent total body clearance (CL/F) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Measured: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Number of participants with positive/negative antidrug antibodies (ADA) result for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to immunogenicity following multiple dosing by the SC route.
Measured: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)
ADA titers testing for all ADA-positive samples as measure of immunogenicity
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to immunogenicity following multiple dosing by the SC route.
Measured: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start20 Apr 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Osteoarthritis of the KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770428
- Sponsor's protocol ID
- D5680C00004
- Other IDs
- 2020-005982-14
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2021
- Last updated
- 15 Dec 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Doses of MEDI7352 Administered by the Subcutaneous Route in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT04770428
- Acronym / sponsor ID
- D5680C00004
- Conditions
- Painful Osteoarthritis of the Knee
- Keywords
- MEDI7352, Bi-specific fusion protein, Multiple doses, Subcutaneous route, Pharmacokinetics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- 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.
This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of MEDI7352 in healthy participants.
Detailed description
The study will comprise:
- A Screening Period of up to 36 days (approximately 5 weeks);
- A Treatment Period of 6 weeks where participants will be given 1 dose of study treatment every 2 weeks (4 doses in total). Participants will be required to stay in the Clinical Unit from Days -1 to 8 (Visit 2), from Days 14 to 15 (Visit 6), from Days 28 to 29 (Visit 9), and from Days 42 to 50 (Visit 12). In addition, participants will have multiple visits to the Clinical Unit to complete the study assessments;
- A Follow-up Period of 42 days (6 weeks) where participants will also have multiple visits to the Clinical Unit to complete the study assessments, and;
- A final Follow-up Visit after 42 days after the Treatment Period.
Participants will receive fixed multiple subcutaneous (SC) doses of MEDI7352 or placebo on 4 occasions; one dose every 2 weeks on Days 1, 15, 29 and 43, under fasted conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Japanese MEDI7352 | Experimental | Drug: MEDI7352Randomized Japanese participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 1: Japanese Placebo | Placebo comparator | Drug: PlaceboRandomized Japanese participants will receive matching placebo subcutaneously. |
| Cohort 2: Caucasian MEDI7352 | Experimental | Drug: MEDI7352Randomized Caucasian participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 2: Caucasian Placebo | Placebo comparator | Drug: PlaceboRandomized Caucasian participants will receive matching placebo subcutaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female of non childbearing potential participants aged 18 to 65 (inclusive) years for Caucasian participants and 20 to 65 (inclusive) years for Japanese participants with suitable veins for cannulation or repeated venepuncture
- Japanese or Caucasian ethnicity
- Post-menopausal women must have had ≥ 12 months of spontaneous amenorrhea with an follicle stimulating hormone (FSH) concentration consistently ≥ 40 mIU/mL and a negative serum or urine pregnancy test result at Screening or Day -1. Surgically sterile women must have had a hysterectomy, and bilateral ovariectomy (oophorectomy), must provide documentation of the procedure and have had a negative serum or urine pregnancy test at Screening or Day -1. An intermediate or positive pregnancy test, can be confirmed by repeating the pregnancy test and demonstrating non-doubling of β-human chorionic gonadotropin levels every 48 to 72 hours
- Men who are biologically capable of fathering children must agree and commit to use of an adequate form of a highly effective method of contraception and refrain from sperm donation for the duration of the Treatment Period and for 3 months after the last administration of study treatment
- Body mass index 18 and 30 kg/m^2, weight at least 50 kg
Key exclusion criteria (19 listed)
- Participation in another clinical study or use of any experimental medication, device, or biologic with an investigational product (IP) within 5 half-lives of that IP or 3 months (whichever is longer) prior to first dosing
- Participation in another study investigating any form of anti-NGF or anti-TNF therapy in the 6 months prior to Screening and until after the final Follow-up Visit
- Any positive laboratory result at screening for COVID-19
- Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 prior to Screening
- Inability to comply with study-related restrictions and requirements related to consumption of alcohol, provision of meals and snacks, nicotine use, activity, blood donation, and contraception
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 |
|---|---|---|
| MEDI7352A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions. | Drug | Cohort 1: Japanese MEDI7352, Cohort 2: Caucasian MEDI7352 |
| PlaceboMatching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions. | Drug | Cohort 1: Japanese Placebo, Cohort 2: Caucasian Placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Upto Final Follow-up (Day 84) or Early Termination
To evaluate the safety and tolerability of MEDI7352 in healthy Japanese and Caucasian participants following multiple dosing by the SC route
11 secondary outcomes
Maximum concentration (Cmax) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Time of Cmax (tmax) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to infinity (AUCinf) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable serum concentration (AUClast) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve for the dosing interval (AUCτ) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Average drug concentration over a dosing interval (Cavg) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent volume of distribution at steady state (Vss/F) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Half-life (t1/2) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent total body clearance (CL/F) for MEDI7352
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Number of participants with positive/negative antidrug antibodies (ADA) result for MEDI7352
Time frame: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)
ADA titers testing for all ADA-positive samples as measure of immunogenicity
Time frame: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)
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 Dec 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI7352 in people with Painful Osteoarthritis of the Knee, run by AstraZeneca at 1 site in United Kingdom.
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 8 inclusion and 19 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 (AEs) (time frame: Upto Final Follow-up (Day 84) or Early Termination). 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 Dec 2021.