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

AstraZeneca

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).

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 ascendi…

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

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 as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China. * For Japanese participants (Part B2): participants are to be Japanese, defined as having both…

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
Research Site
Chicago, Illinois
Research Site
Ann Arbor, Michigan
Research Site
Saint Paul, Minnesota
Research Site
San Antonio, Texas