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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
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes * eGFR = 45 to 90 mL/min /1.73m2 * Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive). * Females are to be of non-childbearing potential Exclusion Criteria: * As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the participant to participate in the study. * Positive hepatitis C antibody, hepatitis B virus surface antigen, or human immunodeficiency virus test, at screening. * History of QT prolongation associated with other medications that required discontinuation of that medication. * Congenital long QT syndrome. * History of ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR \< 100 bpm can be eligible as judged by the investigator. * Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator. * Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator. * Systolic BP \> 160 mmHg or diastolic BP \> 100mmHg or HR \< 50 bpm or \> 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit. * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy. * Kidney cyst interventions such as cyst aspiration or cyst fenestration within 12 weeks prior to screening and during the screening period, or such interventions planned or anticipated within the follow-up period.
About the study
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
What is being tested
- AZD1613 - Part A (drug)
- Placebo - Part A (drug)
- AZD1613 - Part B (drug)
- Placebo - Part B (drug)
Sponsor: AstraZeneca · Participants: 40 · Started: Nov 10, 2025
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07228364
Locations in the U.S.
| Alabama | Research Site, Birmingham (Not yet recruiting) |
| California | Research Site, Loma Linda (Not yet recruiting) |
| Florida | Research Site, Jacksonville Research Site, Orlando |
| Kansas | Research Site, Lenexa |
| Maryland | Research Site, Baltimore (Not yet recruiting) |
| Minnesota | Research Site, Rochester |
| Texas | Research Site, San Antonio (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.