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MEDI7352 · 2 trials · 1 indication
Change from baseline in weekly average of daily NRS pain score to Week 12 is reported. The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This was recorded on a daily basis at approximately the same time every morning via electronic patient recorded outcome (ePRO) diary. A two-step multiple imputation procedure was used to address missing post-baseline scores.
To evaluate the safety and tolerability of MEDI7352 in healthy Japanese and Caucasian participants following multiple dosing by the SC route
| Arm | Type | Description |
|---|---|---|
| MEDl7352 Dose 1 | EXPERIMENTAL | Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 2 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 2 injection Q2W during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 3 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 3 injection Q2W during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 4 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 4 injection Q2W during a 12-week parallel-group treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period. |
| Cohort 1: Japanese MEDI7352 | EXPERIMENTAL | Randomized Japanese participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 1: Japanese Placebo | PLACEBO_COMPARATOR | Randomized Japanese participants will receive matching placebo subcutaneously. |
| Cohort 2: Caucasian MEDI7352 | EXPERIMENTAL | Randomized Caucasian participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 2: Caucasian Placebo | PLACEBO_COMPARATOR | Randomized Caucasian participants will receive matching placebo subcutaneously. |
| Name | Type | Description |
|---|---|---|
| MEDI7352 | DRUG | Participants will receive SC injection of MEDI7352 as stated in arm description. |
| Placebo | OTHER | Participants will receive SC injection of placebo as stated in arm description. |
Inclusion Criteria: 1. Participants must understand the nature of the study and must give signed and dated written informed consent prior to the initiation of any study procedures, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this...
MEDI7352 is an investigational small molecule being developed for painful osteoarthritis of the knee. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. Two clinical trials have been completed, including a Phase 2 efficacy and safety study and a Phase 1 healthy volunteer study.
MEDI7352 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in Phase 2 clinical development for painful osteoarthritis of the knee, with two completed trials involving a total of 369 participants.
MEDI7352 is in Phase 2 clinical development for painful osteoarthritis of the knee. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two clinical trials have been completed, including a Phase 2 study and a Phase 1 study in healthy volunteers.
MEDI7352 has completed two clinical trials. The Phase 2 trial NCT04675034 enrolled 345 participants with painful osteoarthritis of the knee across Denmark, Estonia, Germany, Poland, Spain, and the United Kingdom. The Phase 1 trial NCT04770428 enrolled 24 healthy volunteers in the United Kingdom to evaluate safety, tolerability, pharmacokinetics, and immunogenicity.
MEDI7352 is not FDA approved. It is an investigational drug in Phase 2 clinical development for painful osteoarthritis of the knee. Two clinical trials have been completed, but the drug remains in clinical development and has not received regulatory approval for any use.
MEDI7352 is a small molecule drug being developed by AstraZeneca PLC for painful osteoarthritis of the knee. It is currently in Phase 2 clinical development, with two completed trials. The drug is administered to participants in randomized, double-blind, placebo-controlled studies.