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RECRUITING
NCT07228364
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

DRUG

AZD1613 - Part A

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

DRUG

Placebo - Part A

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

DRUG

AZD1613 - Part B

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

DRUG

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