Recruiting
Phase 1

AZD4248

Sponsor:

AstraZeneca

Code:

NCT07024823

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

AZD4248

Placebo

AZD4248

Placebo

Study Details

Brief 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).

Conditions

Chronic Kidney Disease

Study ID

NCT07024823

Start date

Jun 9, 2025

Status verified date

Aug, 2026

Completion date

Dec 25, 2026

Anticipated

Primary completion date

Dec 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.

Part C:

  • Have a BMI between 20 and 40 kg/m2, inclusive.
  • Have a diagnosis of diabetic kidney disease (DKD).
  • Hemoglobin A1C (HbA1c) of ≤ 10.5%.
  • Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.

Part D:

  • Have a BMI between 20 and 35 kg/m2, inclusive.
  • Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values.
  • HbA1c of ≤ 10.5%.
  • Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.
  • Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff.
  • Participants must be able to read and understand English sufficient to participate in site visits and home testing.

Key Exclusion Criteria:

  • History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.
  • Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV).

Parts A and B:

  • History or presence of gastrointestinal, hepatic, or renal disease.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.
  • Participants who have previously received AZD4248.

Part C:

  • History or presence of gastrointestinal, hepatic, or renal disease.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.
  • Use of drugs that are strong or moderate CYP3A4 inhibitors/inducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection.
  • Participants who have previously received AZD4248.
  • Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.
  • Expected change of dosing regimen during the study.
  • History of clinically significant heart or vascular disease.
  • New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening.
  • Ventricular arrhythmias requiring treatment.
  • Amputation due to peripheral artery disease.
  • Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months.

Part D:

  • Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.
  • Expected change of dosing regimen during the study.

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A1 SAD

Participants will receive single ascending oral dose of AZD4248 or placebo.

experimental: Part A2 SAD Chinese Cohort

Participants will receive single oral dose of AZD4248 or placebo.

experimental: Part A3 SAD IV Cohort

Participants will receive single IV infusion of AZD4248 or placebo.

experimental: Part B1 MAD

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

experimental: Part B2 MAD Japanese

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

experimental: Part C Multiple Dosing DKD

Participants will receive multiple oral doses of AZD4248 or placebo.

no intervention: Part D Observational Cohort

Participants will participate in home-based creatinine self-measurement.

Interventions

AZD4248

AZD4248 will be administered orally.

Placebo

Placebo will be administered orally.

AZD4248

AZD4248 will be administered via IV infusion.

Placebo

Placebo will be administered via IV infusion.

Primary outcome measure

  • Parts A, B, and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 to Follow Up visit (Part A: up to 12 days; Part B and C: up to 19 days) ]
  • Part D: Intra- and inter-participant variability of estimated glomerular filtration rate (eGFR) derived from home self-testing device measurements [ Time Frame: Day 1 to Day 169 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

Research Site

Recruiting

Chicago, Illinois, United States, 60643

Research Site

Recruiting

Saint Paul, Minnesota, United States, 55114

Research Site

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

AstraZeneca

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Type 2 Diabetes
  • Diabetic Kidney Disease
  • Multiple Ascending Dose
  • Single Ascending Dose
  • Creatinine
  • Food Effect
  • Pharmacokinetics
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-12.