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
7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
AstraZeneca
Lead sponsor
Parexel
Collaborator