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Tests treatment safety and results for Chronic Kidney Disease
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
ClinicalTrials.gov ID: NCT07024823
What this study is testing
What is AZD4248?
AZD4248 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Key \- 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...
- For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This...
- Have a BMI between 20 and 40 kg/m2, inclusive.
You likely can't join if
- History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the...
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus...
- 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...
- Participants who have previously received AZD4248. Part C:
See the full eligibility criteria
- Key \- 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...
- 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...
- 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...
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Saint Paul, Minnesota, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Chicago, Illinois, United States; Ann Arbor, Michigan, United States; Saint Paul, Minnesota, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.