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Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
NCT07228364 · View on ClinicalTrials.gov ↗
Study Summary
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
Conditions Studied
Interventions
- DRUG AZD1613 - Part A
- DRUG Placebo - Part A
- DRUG AZD1613 - Part B
- DRUG Placebo - Part B
Study Locations (15)
Other
- Research Site — Chengdu
- Research Site — Hangzhou
- Research Site — Nanjing
- Research Site — Shanghai
- Research Site — Wuhan
- Research Site — Xiamen
- Research Site — London
Florida
- Research Site — Jacksonville
- Research Site — Orlando
Alabama
- Research Site — Birmingham
California
- Research Site — Loma Linda
Kansas
- Research Site — Lenexa
Maryland
- Research Site — Baltimore
Minnesota
- Research Site — Rochester
Texas
- Research Site — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-11-10 |
| Est. Completion | 2027-01-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07228364
The ClinicalTrials.gov registry entry for NCT07228364 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease appearing as the primary indexed condition, and to 4 interventions — of which AZD1613 - Part A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07228364 reports 15 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07228364 about?
NCT07228364 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease". A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
What is the current status of trial NCT07228364?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-11-10. Estimated completion is 2027-01-04.
What conditions does trial NCT07228364 study?
This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07228364?
The interventions under investigation include: AZD1613 - Part A (DRUG), Placebo - Part A (DRUG), AZD1613 - Part B (DRUG), Placebo - Part B (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07228364?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07228364 being conducted?
This trial has 15 study locations across Alabama, California, Florida, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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