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AZD4248 · 1 trial · 1 indication
To assess the safety and tolerability of AZD4248 following single oral ascending doses or single IV administration to healthy participants and multiple oral ascending doses to healthy participants and participants with CKD and T2D (DKD).
To assess intra- and inter-participant variability of twice weekly home-based serum creatinine measurements.
| Arm | Type | Description |
|---|---|---|
| Part A1 SAD | EXPERIMENTAL | Participants will receive single ascending oral dose of AZD4248 or placebo. |
| Part A2 SAD Chinese Cohort | EXPERIMENTAL | Participants will receive single oral dose of AZD4248 or placebo. |
| Part A3 SAD IV Cohort | EXPERIMENTAL | Participants will receive single IV infusion of AZD4248 or placebo. |
| Part B1 MAD | EXPERIMENTAL | Participants will receive multiple ascending oral doses of AZD4248 or placebo. |
| Part B2 MAD Japanese | EXPERIMENTAL | Participants will receive multiple ascending oral doses of AZD4248 or placebo. |
| Part C Multiple Dosing DKD | EXPERIMENTAL | Participants will receive multiple oral doses of AZD4248 or placebo. |
| Part D Observational Cohort | NO_INTERVENTION | Participants will participate in home-based creatinine self-measurement. |
| Name | Type | Description |
|---|---|---|
| AZD4248 | DRUG | AZD4248 will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
Key Inclusion Criteria: \- Healthy participants with suitable veins for cannulation or repeated venipuncture. Parts A and B: * Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive. * For Chinese participants (Part A2): participants are to be Chinese, defined ...
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AZD4248 is an investigational small molecule being developed for the treatment of Chronic Kidney Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
AZD4248 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of this investigational drug.
AZD4248 is currently in Phase 1 clinical development. This is the earliest stage of testing in humans, focused primarily on assessing the drug's safety, tolerability, and how it is processed by the body. It is not yet approved for any use and remains an investigational agent.
AZD4248 is being studied in a Phase 1 clinical trial registered as NCT07024823. This trial is recruiting participants and aims to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD4248 in healthy participants and in those with Chronic Kidney Disease and Type 2 Diabetes.
Yes, the Phase 1 clinical trial of AZD4248, NCT07024823, includes healthy volunteers as well as participants with Chronic Kidney Disease and Type 2 Diabetes. The study is designed to evaluate the drug's safety and how it behaves in the body across these different groups.