Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Start Date
11/10/2025
Completion Date
5/22/2027
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).
Detailed Description
This Phase I, randomised, single-blind, placebo-controlled study will assess the safety and tolerability of AZD1613 and characterise the pharmacokinetics (PK) of AZD1613 in participants with autosomal dominant polycystic kidney disease (ADPKD), following subcutaneous (SC) or intravenous (IV) administration. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD1613. Furthermore, the safety and PK profile will be evaluated in Chinese participants with ADPKD to assess any potential race effect in this population.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
AZD1613 - Part A
Placebo - Part A
AZD1613 - Part B
Placebo - Part B
Conditions
Locations
Research Site
Birmingham, Alabama 35233
United States
Research Site
Loma Linda, California 92354
United States
Research Site
Jacksonville, Florida 32216
United States
Research Site
Orlando, Florida 32808
United States
Research Site
Lenexa, Kansas 66219
United States
Research Site
Baltimore, Maryland 21201
United States
Research Site
Rochester, Minnesota 55905
United States
Research Site
San Antonio, Texas 78212
United States
Research Site
Chengdu, 610072
China
Research Site
Hangzhou, 310003
China
Research Site
Nanjing, 210009
China
Research Site
Shanghai, 200025
China
Research Site
Wuhan, 430022
China
Research Site
Xiamen, 361101
China
Research Site
London, NW3 2QG
United Kingdom