Phase I Study of AZD1613 Safety, Tolerability, and Pharmacokinetics in Adults with Autosomal Dominant Polycystic Kidney Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics the drug AZD1613 in adults with autosomal dominant polycystic kidney disease ADPKD. This Phase I, randomized, single-blind, placebo-controlled study also aims to understand any differences in safety and drug processing in Chinese participants with ADPKD. Including participants who receive placebo helps compare the effects and safety of AZD1613 accurately. Participants will receive four doses of either AZD1613 or placebo on days 1, 29, 57, and 85. The drug is administered either under the skin subcutaneous or through an intravenous line. The study is designed with multiple groups, including separate cohorts for Chinese participants, to assess the drugs safety and pharmacokinetics across different populations. Throughout the study, participants will undergo various assessments including heart monitoring with 12-lead ECGs, blood tests to check liver and kidney function, blood pressure and vital signs measurements, and urine testing for kidney markers. These evaluations occur from baseline before dosing through follow-up visits up to approximately day 189. Researchers will track any adverse events, changes in heart electrical activity, and levels of the drug in the body to understand its effects and safety over time.

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