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RECRUITING
NCT07024823
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-06-09

Completion Date

2026-06-18

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

DRUG

AZD4248

AZD4248 will be administered orally.

DRUG

Placebo

Placebo will be administered orally.

DRUG

AZD4248

AZD4248 will be administered via IV infusion.

DRUG

Placebo

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