Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-04-20
124
Participants Needed
5
Research Sites
53 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants with suitable veins for cannulation or repeated venipuncture
- For Parts A and B: BMI between 18 and 30 kg/m2 inclusive
- For Chinese participants (Part A2): must have Chinese ancestry through both parents and all grandparents
- For Japanese participants (Part B2): must have Japanese ancestry through both parents and all grandparents
- For Part C: BMI between 20 and 35 kg/m2 inclusive
- For Part C: diagnosis of diabetic kidney disease (DKD)
- For Part C: Hemoglobin A1C of 10.5% or less
- For Part C: stable dose of ACE inhibitor or angiotensin receptor blocker for at least 6 weeks before screening and during screening
- For Part C: stable doses of all other medications for at least 6 weeks before screening
- For Part D: BMI between 20 and 35 kg/m2 inclusive
- For Part D: diagnosis of DKD defined by type 2 diabetes, eGFR, and urine albumin to creatinine ratio
- For Part D: Hemoglobin A1C of 10.5% or less
- For Part D: stable dose of ACE inhibitor or angiotensin receptor blocker for at least 6 weeks before screening and during screening
- For Part D: stable doses of all other medications for at least 6 weeks before screening
- For Part D: able and motivated to use home creatinine device and smartphone independently without assistance
- For Part D: able to read and understand English to participate in visits and home testing
You will not qualify if you...
- History of any clinically important disease or disorder that may increase risk or affect study results
- Positive screening for hepatitis B surface antigen, hepatitis B core antibody, or HIV
- For Parts A and B: history or presence of gastrointestinal, liver, or kidney disease
- For Parts A and B: any significant illness, surgery, or trauma within 4 weeks before first dose
- For Parts A and B: history of severe allergy or hypersensitivity or allergy to drugs similar to AZD4248
- For Parts A and B: previous use of AZD4248
- For Part C: history or presence of gastrointestinal, liver, or kidney disease
- For Part C: any significant illness, surgery, or trauma within 4 weeks before first dose
- For Part C: history of severe allergy or hypersensitivity or allergy to drugs similar to AZD4248
- For Part C: use of strong or moderate CYP3A4 or P-gp inhibitors or inducers within 3 weeks before screening until last sample collection
- For Part C: previous use of AZD4248
- For Part C: serum creatinine-altering drugs must be stable long-term use before study entry
- For Part C: expected change in dosing regimen during study
- For Part C: history of significant heart or vascular disease
- For Part C: New York Heart Association Class 2, 3, or 4 heart failure or hospitalization for heart failure within 6 months
- For Part C: ventricular arrhythmias requiring treatment
- For Part C: amputation due to peripheral artery disease
- For Part C: severe COPD or hospitalization for exacerbation within last 6 months
- For Part D: serum creatinine-altering drugs must be stable long-term use before study entry
- For Part D: expected change in dosing regimen during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Research Site
Glendale, California, United States, 91206
Actively Recruiting
2
Research Site
Chicago, Illinois, United States, 60643
Actively Recruiting
3
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Research Site
Saint Paul, Minnesota, United States, 55114
Actively Recruiting
5
Research Site
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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