RecruitingPhase 1NCT07024823

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort

A Phase I Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 Following Single and Multiple Ascending Dose Administration in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Prospective, Non-interventional Cohort Study


Sponsor

AstraZeneca

Enrollment

124 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of AZD4248 administered as an oral solution and intravenous (IV) infusion. Additionally, the study investigates the non-interventional feasibility of home measurement of serum creatinine in participants with diabetic kidney disease (DKD).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD4248 to understand how it is processed by the body, how safe it is, and how it affects kidney function in healthy volunteers as well as patients with diabetic kidney disease (kidney damage caused by type 2 diabetes). **You may be eligible if...** - You are a healthy adult with suitable veins for blood draws - You have a BMI between 18 and 30 (or 20–35 if you have diabetic kidney disease) - For the patient group: you have been diagnosed with diabetic kidney disease - For the patient group: your HbA1c (blood sugar average) is 10.5% or below - For the patient group: you have been on a stable dose of ACE inhibitor or ARB blood pressure medication for at least 6 weeks **You may NOT be eligible if...** - You have other significant health conditions that could affect the study results - You do not meet the specific BMI or background criteria for your study group - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD4248

AZD4248 will be administered orally.

DRUGPlacebo

Placebo will be administered orally.

DRUGAZD4248

AZD4248 will be administered via IV infusion.

DRUGPlacebo

Placebo will be administered via IV infusion.


Locations(5)

Research Site

Glendale, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Saint Paul, Minnesota, United States

Research Site

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07024823


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