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

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07024823
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AZD4248 — DRUG
    AZD4248 will be administered orally.
  • Placebo — DRUG
    Placebo will be administered orally.
  • AZD4248 — DRUG
    AZD4248 will be administered via IV infusion.
  • Placebo — DRUG
    Placebo will be administered via IV infusion.

Study Details

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).

Key Dates

Start date
Jun 9, 2025
Status verified
Apr 2026
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteChicagoIllinois60643-
Research SiteAnn ArborMichigan48109-
Research SiteSaint PaulMinnesota55114-
Research SiteSan AntonioTexas78215-

Find similar trials in Glendale, CA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Research Site· Glendale, CAResearch Site· Chicago, ILResearch Site· Ann Arbor, MIResearch Site· Saint Paul, MNResearch Site· San Antonio, TX

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