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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAstraZeneca

About this trial

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).

Eligibility criteria

Qualifiers

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.

Have a BMI between 20 and 40 kg/m2, inclusive.

Disqualifiers

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).

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.

Trial design

Treatments tested in this trial

  • AZD4248
  • Placebo
  • AZD4248
  • Placebo

Treatment groups

124 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

5
Research Site91206, GlendaleCalifornia, United States
Research Site60643, ChicagoIllinois, United States
Research Site48109, Ann ArborMichigan, United States
Research Site55114, Saint PaulMinnesota, United States

Sponsors and collaborators

AstraZeneca

Lead sponsor

Parexel

Collaborator