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Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Sponsor: AstraZeneca
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-11-10
Completion Date
2027-01-04
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
AZD1613 - Part A
Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Placebo - Part A
Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
AZD1613 - Part B
Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Placebo - 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