RecruitingPhase 1NCT07228364

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

A Phase I Randomised, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1613 Following Multiple Ascending Dose Administration in Participants With Autosomal Dominant Polycystic Kidney Disease


Sponsor

AstraZeneca

Enrollment

40 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AZD1613 - Part A, a drug called AZD1613 - Part B, and others for people with autosomal dominant polycystic kidney disease. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD1613 - Part A

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

DRUGPlacebo - Part A

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

DRUGAZD1613 - Part B

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

DRUGPlacebo - Part B

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


Locations(15)

Research Site

Birmingham, Alabama, United States

Research Site

Loma Linda, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Lenexa, Kansas, United States

Research Site

Baltimore, Maryland, United States

Research Site

Rochester, Minnesota, United States

Research Site

San Antonio, Texas, United States

Research Site

Chengdu, China

Research Site

Hangzhou, China

Research Site

Nanjing, China

Research Site

Shanghai, China

Research Site

Wuhan, China

Research Site

Xiamen, China

Research Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07228364


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