Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07228364
Phase
PHASE1
Status
Recruiting
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Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD1613 - Part A — DRUG
    Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Placebo - Part A — DRUG
    Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
  • AZD1613 - Part B — DRUG
    Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Placebo - Part B — DRUG
    Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

Study Details

A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).

Key Dates

Start date
Nov 10, 2025
Status verified
Apr 2026
Primary completion
Jan 26, 2027
Completion
Jan 26, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Cohort A1
    Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
  • Experimental: Part A - Cohort A2
    Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
  • Experimental: Part B - Chinese Cohort
    Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteLoma LindaCalifornia92354-
Research SiteJacksonvilleFlorida32216-
Research SiteOrlandoFlorida32808-
Research SiteLenexaKansas66219-
Research SiteBaltimoreMaryland21201-
Research SiteRochesterMinnesota55905-
Research SiteSan AntonioTexas78212-

Find similar trials in Birmingham, AL

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Research Site· Birmingham, ALResearch Site· Loma Linda, CAResearch Site· Jacksonville, FLResearch Site· Orlando, FLResearch Site· Lenexa, KSResearch Site· Baltimore, MD

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