NCT07024823

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a Phase I, first in human (FIH), randomized, single-blind, placebo-controlled study of AZD4248 involving healthy participants (Parts A and B) and participants with DKD (Part C) and to assess home measurements of creatinine in a prospective, non-interventional cohort in participants with DKD (Part D). The study consists of 4 parts: * Part A: SAD. Part A will consist of Parts A1 (single ascending doses in healthy participants), A2 (single dose in healthy Chinese participants), and A3 (IV infusion in healthy participants). * Part B: MAD. Part B will consist of Parts B1 (multiple ascending doses in healthy participants) and B2 (multiple ascending doses in healthy participants of Japanese descent). * Part C: Multiple dosing in participants with DKD. * Part D: Multi-site, non-interventional, prospective cohort evaluation of home-based creatinine self-measurement in participants with DKD.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-06-18
• Completion: 2026-06-18
• First posted: 2025-06-17
• Last updated: 2026-03-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study