RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AZD4248, how the body handles it, and how it affects the body. The drug is given by mouth or through a vein to healthy people and people with long-term kidney disease and type 2 diabetes. A separate group tests home measurement of creatinine, a blood marker used to check kidney function, without receiving the study drug.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Healthy participants need veins suitable for placing a small tube or taking blood often.
  • Parts A and B: BMI, a measure of weight compared with height, must be 18–30.
  • Part A2: Both parents and all 4 grandparents must be Chinese. Part B2: Both parents and all 4 grandparents must be Japanese. Families may live outside China or Japan.
  • Part C: BMI must be 20–40, and you must have kidney disease caused by diabetes.
  • Part D: BMI must be 20–35. You must have type 2 diabetes and kidney disease based on blood and urine tests.
  • Parts C and D: A1C, a measure of average blood sugar, must be 10.5% or less.
  • Parts C and D: You must take a steady dose of an ACE inhibitor or ARB, medicines used for blood pressure, for at least 6 weeks before Visit 1 and during screening. Other medicine doses must be steady for at least 6 weeks before screening.
  • Part D: You must be able and willing to use the home test device and smartphone without help. You must read and understand enough English for visits and home tests.

Who can't join

  • All parts: A major illness or health problem that could make the study unsafe or affect its results, or a positive screening test for hepatitis B markers or HIV.
  • Parts A, B, and C: Past or current stomach, bowel, liver, or kidney disease is listed as a reason you cannot join.
  • Parts A, B, and C: A major illness, medical procedure, surgery, or injury within 4 weeks before the first study dose.
  • Parts A, B, and C: A past severe allergy, a major ongoing allergy, an allergy to drugs like AZD4248, or any past use of AZD4248.
  • Part C: Use of certain drugs that change how the body handles medicines, starting 3 weeks before screening through the last sample collection.
  • Parts C and D: Expected changes to medicine dosing during the study. Medicines that change creatinine levels must already be taken long-term at a steady dose.
  • Part C: Major heart or blood vessel disease; class 2, 3, or 4 heart failure; a heart failure hospital stay within 6 months; lower heart chamber rhythm problems needing treatment; or limb removal due to poor blood flow.
  • Part C: Severe COPD, a long-term lung disease, or a hospital stay for worsening COPD within the last 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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 sites (5)

CA

IL

MI

MN

TX